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Trial record 71 of 383 for:    FERRIC CATION

Continuous Soluble Ferric Pyrophosphate (SFP) Iron Delivery Via Dialysate in Hemodialysis Patients (CRUISE 2)

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ClinicalTrials.gov Identifier: NCT01322347
Recruitment Status : Completed
First Posted : March 24, 2011
Results First Posted : April 24, 2015
Last Update Posted : April 26, 2017
Sponsor:
Information provided by (Responsible Party):
Rockwell Medical Technologies, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Renal Failure Chronic Requiring Hemodialysis
Interventions Drug: Soluble Ferric Pyrophosphate (SFP)
Device: Standard dialysate
Enrollment 294
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Soluble Ferric Pyrophosphate (SFP) in Dialysate Standard Dialysate (Placebo)
Hide Arm/Group Description

11 micrograms (µg) of iron / deciliter (dL) of dialysate.

Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks.

0 micrograms (µg) of iron / deciliter (dL) of dialysate.

Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks.

Period Title: Overall Study
Started 147 147
Completed 48 Wks in St 2 28 22
Comp St 2 Due to ESA/IV Iron Needs 68 90
Enrolled in St 3 101 113
Completed St 3 82 86
Completed 96 112
Not Completed 51 35
Reason Not Completed
Adverse Event             7             2
Death             5             3
Physician Decision             2             1
Protocol Violation             5             2
Withdrawal by Subject             1             4
non-protocol change to ESA or IV iron             14             6
blood transfusion             5             5
sponsor decision             1             3
ineligible             6             3
kidney transplant             3             1
study drug withheld > 12 wks             0             1
moved/changed dialysis             2             4
Arm/Group Title Soluble Ferric Pyrophosphate (SFP) in Dialysate Standard Dialysate (Placebo) Total
Hide Arm/Group Description

11 micrograms (µg) of iron / deciliter (dL) of dialysate.

Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks.

0 micrograms (µg) of iron / deciliter (dL) of dialysate.

Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks.

Total of all reporting groups
Overall Number of Baseline Participants 147 147 294
Hide Baseline Analysis Population Description
intent-to-treat: all randomized subjects, regardless of whether they received any study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 147 participants 147 participants 294 participants
58.1  (12.68) 59.0  (14.38) 58.5  (13.54)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 147 participants 147 participants 294 participants
Female
65
  44.2%
54
  36.7%
119
  40.5%
Male
82
  55.8%
93
  63.3%
175
  59.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 147 participants 147 participants 294 participants
Hispanic or Latino
33
  22.4%
36
  24.5%
69
  23.5%
Not Hispanic or Latino
114
  77.6%
111
  75.5%
225
  76.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 147 participants 147 participants 294 participants
American Indian or Alaska Native
0
   0.0%
3
   2.0%
3
   1.0%
Asian
8
   5.4%
4
   2.7%
12
   4.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
2
   1.4%
2
   0.7%
Black or African American
64
  43.5%
54
  36.7%
118
  40.1%
White
73
  49.7%
83
  56.5%
156
  53.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
2
   1.4%
1
   0.7%
3
   1.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 147 participants 147 participants 294 participants
United States 128 123 251
Canada 19 24 43
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeters
Number Analyzed 147 participants 147 participants 294 participants
168.80  (10.238) 170.01  (9.944) 169.40  (10.093)
Post-dialysis weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 147 participants 147 participants 294 participants
86.64  (22.270) 85.09  (23.474) 85.86  (22.857)
1.Primary Outcome
Title Change From Baseline Hemoglobin at End-of-Treatment: Least-Squares Mean
Hide Description Mean change from baseline Hgb (the average of the three most recent Hgb values preceding randomization) assessments during the last one-sixth of the treatment period for patients who prematurely withdraw from study treatment, but will include a minimum of at least the last two Hgb values. Value is expressed as least-squares mean, along with standard error.
Time Frame Hgb measured weekly; up to 48 weeks from date of randomization
Hide Outcome Measure Data
Hide Analysis Population Description
modified intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin value measured.
Arm/Group Title Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate Stage 2 Placebo (Standard Dialysate)
Hide Arm/Group Description:

11 micrograms (µg) of iron / deciliter (dL) of dialysate.

Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks.

0 micrograms (µg) of iron / deciliter (dL) of dialysate.

Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks.

Overall Number of Participants Analyzed 142 144
Least Squares Mean (Standard Error)
Unit of Measure: grams per liter
-0.5  (1.08) -4.0  (1.09)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate, Stage 2 Placebo (Standard Dialysate)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.011
Comments LS Mean (SE) and p-value are from ANCOVA model with baseline Hgb as covariate. Model also includes indicator variable for baseline ESA dose stratum.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means between SFP & PBO
Estimated Value 3.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.39
Estimation Comments [Not Specified]
2.Primary Outcome
Title Change From Baseline Hemoglobin at End-of-Treatment: Mean Baseline and End-of-Treatment Hemoglobin
Hide Description Mean change from baseline Hgb (the average of the three most recent Hgb values preceding randomization) assessments during the last one-sixth of the treatment period for patients who prematurely withdraw from study treatment, but will include a minimum of at least the last two Hgb values. Values expressed are mean baseline and end-of-treatment Hgb, along with the mean difference (standard deviation).
Time Frame Hgb measured weekly; up to 48 weeks from date of randomization
Hide Outcome Measure Data
Hide Analysis Population Description
modified intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin value measured.
Arm/Group Title Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate Stage 2 Placebo (Standard Dialysate)
Hide Arm/Group Description:

11 micrograms (µg) of iron / deciliter (dL) of dialysate.

Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks.

0 micrograms (µg) of iron / deciliter (dL) of dialysate.

Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks.

Overall Number of Participants Analyzed 142 144
Mean (Standard Deviation)
Unit of Measure: grams per liter
Baseline Hemoglobin 109.6  (6.09) 109.3  (6.25)
End-of-Treatment Hemoglobin 108.7  (13.81) 104.9  (13.33)
Mean Change in Hemoglobin from at End-of- -0.9  (11.76) -4.5  (11.71)
3.Secondary Outcome
Title Mean Change in Serum Iron From Pre-Dialysis to Post-Dialysis
Hide Description The mean difference between the pre-dialysis and post-dialysis serum iron was calculated, using all post-baseline values obtained during Stage 2. Subjects could participate in Stage 2 for up to 48 weeks, provided that they did not complete Stage 2 early due to a protocol-mandated change in anemia management or withdraw from the study entirely for other reasons.
Time Frame Up to 48 weeks from date of randomization
Hide Outcome Measure Data
Hide Analysis Population Description
modified intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dialysis hemoglobin measured.
Arm/Group Title Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate Stage 2 Placebo (Standard Dialysate)
Hide Arm/Group Description:

11 micrograms (µg) of iron / deciliter (dL) of dialysate.

Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks.

0 micrograms (µg) of iron / deciliter (dL) of dialysate.

Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks.

Overall Number of Participants Analyzed 142 144
Mean (Standard Deviation)
Unit of Measure: micromoles per liter
mean pre-dialysis serum iron 11.634  (3.2506) 11.086  (3.0143)
mean post-dialysis serum iron 31.347  (7.9885) 12.247  (4.0720)
serum iron change from pre- to post-dialysis 19.675  (6.8227) 1.194  (3.4709)
4.Secondary Outcome
Title Mean Change in Transferrin Saturation From Pre-Dialysis to Post-Dialysis
Hide Description The mean difference between the pre-dialysis and post-dialysis TSAT (transferrin) was calculated, using all post-baseline values obtained during Stage 2. Subjects could participate in Stage 2 for up to 48 weeks, provided that they did not complete Stage 2 early due to a protocol-mandated change in anemia management or withdraw from the study entirely for other reasons.
Time Frame Up to 48 weeks from date of randomization
Hide Outcome Measure Data
Hide Analysis Population Description
modified intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin measured.
Arm/Group Title Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate Stage 2 Placebo (Standard Dialysate)
Hide Arm/Group Description:

11 micrograms (µg) of iron / deciliter (dL) of dialysate.

Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks.

0 micrograms (µg) of iron / deciliter (dL) of dialysate.

Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks.

Overall Number of Participants Analyzed 142 144
Mean (Standard Deviation)
Unit of Measure: percent
mean pre-dialysis TSAT (transferrin) 24.7  (6.67) 23.2  (8.35)
mean post-dialysis TSAT (transferrin) 62.3  (13.32) 23.3  (7.80)
pre- to post-dialysis change in TSAT 37.5  (11.46) 0.1  (6.87)
5.Secondary Outcome
Title Mean Change in Unsaturated Iron-Binding Capacity (UIBC) From Pre-Dialysis to Post-Dialysis
Hide Description The mean difference between the pre-dialysis and post-dialysis unsaturated iron binding capacity (UIBC) was calculated, using all post-baseline values obtained during Stage 2. Subjects could participate in Stage 2 for up to 48 weeks, provided that they did not complete Stage 2 early due to a protocol-mandated change in anemia management or withdraw from the study entirely for other reasons.
Time Frame Up to 48 weeks from date of randomization
Hide Outcome Measure Data
Hide Analysis Population Description
modified intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin measured.
Arm/Group Title Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate Stage 2 Placebo (Standard Dialysate)
Hide Arm/Group Description:

11 micrograms (µg) of iron / deciliter (dL) of dialysate.

Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks.

0 micrograms (µg) of iron / deciliter (dL) of dialysate.

Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks.

Overall Number of Participants Analyzed 142 144
Mean (Standard Deviation)
Unit of Measure: micromole per liter
mean pre-dialysis UIBC 30.54  (5.645) 32.19  (6.847)
mean post-dialysis UIBC 17.15  (6.030) 34.75  (7.437)
pre- to post-dialysis change in UIBC -13.31  (5.024) 2.57  (3.345)
6.Secondary Outcome
Title Red Blood Cell or Whole Blood Transfusion: Number of Patients Who Received a Transfusion
Hide Description The number of patients requiring red blood cell or whole blood transfusion while in the randomized treatment stage (Stage 2). Patients remained in Stage 2 until they met protocol-defined criteria for Stage 2 completion or until they had participated in Stage 2 for 48 weeks (whichever came sooner). If a patient was transfused, they were withdrawn from Stage 2.
Time Frame Up to 48 weeks from date of randomization
Hide Outcome Measure Data
Hide Analysis Population Description
intent-to-treat: all randomized subjects
Arm/Group Title Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate Stage 2 Placebo (Standard Dialysate)
Hide Arm/Group Description:

11 micrograms (µg) of iron / deciliter (dL) of dialysate.

Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks.

0 micrograms (µg) of iron / deciliter (dL) of dialysate.

Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks.

Overall Number of Participants Analyzed 147 147
Measure Type: Number
Unit of Measure: participants
6 12
7.Secondary Outcome
Title Red Blood Cell or Whole Blood Transfusion: Number of Units Transfused
Hide Description The total number of units of red blood cells or whole blood that were received by patients while in the randomized treatment stage (Stage 2). This number is the total number of units received across all randomized patients in each treatment group (it is not the average number of units received per patient). Patients remained in Stage 2 until they met protocol-defined criteria for Stage 2 completion or until they had participated in Stage 2 for 48 weeks (whichever came sooner). If a patient was transfused, they were withdrawn from Stage 2.
Time Frame Up to 48 weeks from date of randomization
Hide Outcome Measure Data
Hide Analysis Population Description
intent-to-treat: all randomized subjects
Arm/Group Title Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate Stage 2 Placebo (Standard Dialysate)
Hide Arm/Group Description:

11 micrograms (µg) of iron / deciliter (dL) of dialysate.

Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks.

0 micrograms (µg) of iron / deciliter (dL) of dialysate.

Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks.

Overall Number of Participants Analyzed 147 147
Measure Type: Number
Unit of Measure: units of red blood cells or whole blood
15 29
8.Secondary Outcome
Title Percentage of Change From Baseline to End-of-Treatment for: Reticulocyte Hemoglobin Content (CHr), Ferritin, and the Pre-Dialysis Serum Iron Panel
Hide Description A comparison of the lab values at the end-of-treatment (EoT) to baseline was performed, and the percentage of change from baseline was calculated for the following lab parameters: reticulocyte hemoglobin content (CHr), Ferritin, pre-dialysis unbound iron-binding capacity (UIBC), pre-dialysis serum iron, pre-dialysis transferrin, pre-dialysis total iron-binding capacity TIBC), and transferrin saturation (TSAT).
Time Frame up to 48 weeks from date of randomization
Hide Outcome Measure Data
Hide Analysis Population Description
modified intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin measured.
Arm/Group Title Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate Stage 2 Placebo (Standard Dialysate)
Hide Arm/Group Description:

11 micrograms (µg) of iron / deciliter (dL) of dialysate.

Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks.

0 micrograms (µg) of iron / deciliter (dL) of dialysate.

Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks.

Overall Number of Participants Analyzed 142 144
Mean (Standard Deviation)
Unit of Measure: percentage of change from baseline
CHr percentage of change from baseline -1.62  (4.402) -2.59  (4.490)
Ferritin percentage of change from baseline -11.6  (29.51) -21.7  (68.50)
UIBC percentage of change from baseline 3.77  (14.717) 9.46  (16.537)
Serum Iron percentage of change from baseline 2.470  (31.3742) -7.313  (27.8687)
Transferrin percentage of change from baseline 1.318  (9.3574) 3.988  (10.6940)
TIBC percentage of change from baseline 1.87  (9.472) 3.48  (10.166)
TSAT percentage of change from baseline 0.6  (29.69) -10.5  (25.06)
9.Secondary Outcome
Title Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Unsaturated Iron-Binding Capacity (UIBC), Pre-Dialysis Serum Iron, and Pre-Dialysis Total Iron-Binding Capacity (TIBC)
Hide Description The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Pre-Dialysis Unsaturated Iron-Binding Capacity (UIBC), Pre-Dialysis Serum Iron, and Pre-Dialysis Total Iron-Binding Capacity (TIBC) will be quantified.
Time Frame Up to 48 weeks from date of randomization
Hide Outcome Measure Data
Hide Analysis Population Description
modified intent-to-treat: all randomized subjects who received at least one dose of study medication and had at least one post-dose hemoglobin measured.
Arm/Group Title Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate Stage 2 Placebo (Standard Dialysate)
Hide Arm/Group Description:

11 micrograms (µg) of iron / deciliter (dL) of dialysate.

Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks.

0 micrograms (µg) of iron / deciliter (dL) of dialysate.

Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks.

Overall Number of Participants Analyzed 142 144
Mean (Standard Deviation)
Unit of Measure: micromoles per liter
Baseline UIBC 30.17  (5.866) 30.70  (6.481)
EoT UIBC 31.03  (6.501) 33.24  (7.115)
UIBC Change from Baseline to EoT 0.92  (4.359) 2.56  (4.653)
Baseline Serum Iron 11.663  (3.7879) 11.949  (3.9547)
EoT Serum Iron 11.438  (3.5804) 10.658  (3.3615)
Serum Iron Change from Baseline to EoT -0.244  (3.4146) -1.342  (3.3957)
Baseline TIBC 41.83  (6.184) 42.65  (6.942)
EoT TIBC 42.47  (6.866) 43.90  (6.928)
TIBC Change from Baseline to EoT 0.67  (0.093) 1.22  (4.466)
10.Secondary Outcome
Title Change From Baseline to End-of-Treatment (EoT) in Reticulocyte Hemoglobin (CHr)
Hide Description The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Reticulocyte Hemoglobin (CHr)
Time Frame Up to 48 weeks from date of randomization
Hide Outcome Measure Data
Hide Analysis Population Description
modified intent-to-treat: all randomized subjects who received at least one dose of study medication and had at least one post-dose hemoglobin measured.
Arm/Group Title Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate Stage 2 Placebo (Standard Dialysate)
Hide Arm/Group Description:

11 micrograms (µg) of iron / deciliter (dL) of dialysate.

Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks.

0 micrograms (µg) of iron / deciliter (dL) of dialysate.

Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks.

Overall Number of Participants Analyzed 142 144
Mean (Standard Deviation)
Unit of Measure: picograms
Baseline CHr 32.57  (2.239) 32.54  (1.928)
EoT CHr 32.01  (2.140) 31.69  (2.130)
CHr Change from Baseline to EoT -0.56  (0.021) -0.86  (1.480)
11.Secondary Outcome
Title Change From Baseline to End-of-Treatment (EoT) in Ferritin
Hide Description The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Ferritin
Time Frame Up to 48 weeks from date of randomization
Hide Outcome Measure Data
Hide Analysis Population Description
modified intent-to-treat: all randomized subjects who received at least one dose of study medication and had at least one post-dose hemoglobin measured.
Arm/Group Title Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate Stage 2 Placebo (Standard Dialysate)
Hide Arm/Group Description:

11 micrograms (µg) of iron / deciliter (dL) of dialysate.

Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks.

0 micrograms (µg) of iron / deciliter (dL) of dialysate.

Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks.

Overall Number of Participants Analyzed 142 144
Mean (Standard Deviation)
Unit of Measure: micrograms per liter
Baseline Ferritin 513.6  (201.37) 479.8  (201.52)
EoT Ferritin 446.5  (225.33) 359.3  (278.61)
Ferritin Change from Baseline to EoT -67.1  (164.39) -122.7  (269.70)
12.Secondary Outcome
Title Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin
Hide Description The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin
Time Frame Up to 48 weeks from date of randomization
Hide Outcome Measure Data
Hide Analysis Population Description
modified intent-to-treat: all randomized subjects who received at least one dose of study medication and had at least one post-dose hemoglobin measured.
Arm/Group Title Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate Stage 2 Placebo (Standard Dialysate)
Hide Arm/Group Description:

11 micrograms (µg) of iron / deciliter (dL) of dialysate.

Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks.

0 micrograms (µg) of iron / deciliter (dL) of dialysate.

Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks.

Overall Number of Participants Analyzed 142 144
Mean (Standard Deviation)
Unit of Measure: grams per liter
Baseline Transferrin 1.885  (0.3049) 1.921  (0.3224)
EoT Transferrin 1.902  (0.3267) 1.987  (0.3366)
Transferrin Change from Baseline to EoT 0.019  (0.1839) 0.066  (0.2138)
13.Secondary Outcome
Title Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin Saturation (TSAT)
Hide Description The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin Saturation (TSAT)
Time Frame Up to 48 weeks from date of randomization
Hide Outcome Measure Data
Hide Analysis Population Description
modified intent-to-treat: all randomized subjects who received at least one dose of study medication and had at least one post-dose hemoglobin measured.
Arm/Group Title Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate Stage 2 Placebo (Standard Dialysate)
Hide Arm/Group Description:

11 micrograms (µg) of iron / deciliter (dL) of dialysate.

Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks.

0 micrograms (µg) of iron / deciliter (dL) of dialysate.

Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks.

Overall Number of Participants Analyzed 142 144
Mean (Standard Deviation)
Unit of Measure: percentage
Baseline TSAT 27.9  (8.25) 28.2  (8.58)
EoT TSAT 27.1  (8.01) 24.6  (8.42)
TSAT Change from Baseline to EoT -0.9  (7.65) -3.7  (7.33)
14.Secondary Outcome
Title Variability of Hemoglobin Concentration: Temporal Trend
Hide Description The mean temporal trend of hemoglobin concentration value changes, as measured weekly from baseline until the end of participation in Stage 2.
Time Frame up to 48 weeks from date of randomization
Hide Outcome Measure Data
Hide Analysis Population Description
modified intent-to-treat: all randomized subjects who received at least one dose of study medication and had at least one post dose hemoglobin measured.
Arm/Group Title Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate Stage 2 Placebo (Standard Dialysate)
Hide Arm/Group Description:

11 micrograms (µg) of iron / deciliter (dL) of dialysate.

Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks.

0 micrograms (µg) of iron / deciliter (dL) of dialysate.

Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks.

Overall Number of Participants Analyzed 142 144
Mean (Standard Deviation)
Unit of Measure: grams per liter per week
0.023  (0.222) 0.003  (0.350)
15.Secondary Outcome
Title Variability of Hemoglobin Concentration: Residual Standard Deviation
Hide Description The mean residual standard deviation of the hemoglobin concentration changes, as measured weekly from baseline until the end of participation in Stage 2.
Time Frame up to 48 weeks from date of randomization
Hide Outcome Measure Data
Hide Analysis Population Description
modified intent-to-treat: all randomized subjects who received at least one dose of study medication and had at least one post dose hemoglobin measured.
Arm/Group Title Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate Stage 2 Placebo (Standard Dialysate)
Hide Arm/Group Description:

11 micrograms (µg) of iron / deciliter (dL) of dialysate.

Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks.

0 micrograms (µg) of iron / deciliter (dL) of dialysate.

Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks.

Overall Number of Participants Analyzed 142 144
Mean (Standard Deviation)
Unit of Measure: grams per liter
4.352  (1.501) 4.407  (2.031)
Time Frame In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks.
Adverse Event Reporting Description The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure.
 
Arm/Group Title Stage 2 Standard Dialysate (Placebo) Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate Stage 3 Soluble Ferric Pyrophosphate (SFP)
Hide Arm/Group Description

0 micrograms (µg) of iron / deciliter (dL) of dialysate.

Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week in Stage 2 for up to 48 weeks.

11 micrograms (µg) of iron / deciliter (dL) of dialysate.

Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week in Stage 2 for up to 48 weeks.

11 micrograms (µg) of iron / deciliter (dL) of dialysate.

Soluble Ferric Pyrophosphate (SFP): Upon completion of Stage 2, patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week in Stage 3 for up to 72 weeks of total study participation (Stage 2 + Stage 3).

All-Cause Mortality
Stage 2 Standard Dialysate (Placebo) Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate Stage 3 Soluble Ferric Pyrophosphate (SFP)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Stage 2 Standard Dialysate (Placebo) Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate Stage 3 Soluble Ferric Pyrophosphate (SFP)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   36/145 (24.83%)      44/143 (30.77%)      83/214 (38.79%)    
Blood and lymphatic system disorders       
ANAEMIA   0/145 (0.00%)  0 1/143 (0.70%)  1 3/214 (1.40%)  3
COAGULOPATHY   0/145 (0.00%)  0 1/143 (0.70%)  1 0/214 (0.00%)  0
HAEMORRHAGIC ANAEMIA   0/145 (0.00%)  0 1/143 (0.70%)  1 1/214 (0.47%)  1
LEUKOCYTOSIS   0/145 (0.00%)  0 0/143 (0.00%)  0 1/214 (0.47%)  1
Cardiac disorders       
ACUTE MYOCARDIAL INFARCTION   3/145 (2.07%)  3 0/143 (0.00%)  0 4/214 (1.87%)  4
ANGINA PECTORIS   2/145 (1.38%)  3 0/143 (0.00%)  0 1/214 (0.47%)  1
ANGINA UNSTABLE   0/145 (0.00%)  0 1/143 (0.70%)  1 0/214 (0.00%)  0
AORTIC VALVE STENOSIS   0/145 (0.00%)  0 0/143 (0.00%)  0 2/214 (0.93%)  2
ATRIAL FIBRILLATION   2/145 (1.38%)  2 1/143 (0.70%)  1 8/214 (3.74%)  8
CARDIAC ARREST   0/145 (0.00%)  0 2/143 (1.40%)  2 4/214 (1.87%)  4
CARDIAC FAILURE CONGESTIVE   2/145 (1.38%)  3 4/143 (2.80%)  5 4/214 (1.87%)  5
CARDIOGENIC SHOCK   1/145 (0.69%)  1 0/143 (0.00%)  0 0/214 (0.00%)  0
CARDIOMYOPATHY   0/145 (0.00%)  0 0/143 (0.00%)  0 1/214 (0.47%)  1
CARDIO-RESPIRATORY ARREST   0/145 (0.00%)  0 0/143 (0.00%)  0 2/214 (0.93%)  2
CORONARY ARTERY DISEASE   2/145 (1.38%)  2 0/143 (0.00%)  0 3/214 (1.40%)  3
MYOCARDIAL INFARCTION   1/145 (0.69%)  1 0/143 (0.00%)  0 1/214 (0.47%)  1
PALPITATIONS   1/145 (0.69%)  1 0/143 (0.00%)  0 0/214 (0.00%)  0
SUPRAVENTRICULAR TACHYCARDIA   1/145 (0.69%)  1 1/143 (0.70%)  1 1/214 (0.47%)  1
Congenital, familial and genetic disorders       
CONGENITAL CYSTIC KIDNEY DISEASE   0/145 (0.00%)  0 0/143 (0.00%)  0 1/214 (0.47%)  1
Endocrine disorders       
HYPERPARATHYROIDISM SECONDARY   0/145 (0.00%)  0 1/143 (0.70%)  1 0/214 (0.00%)  0
HYPOTHYROIDISM   1/145 (0.69%)  1 0/143 (0.00%)  0 0/214 (0.00%)  0
Gastrointestinal disorders       
ASCITES   0/145 (0.00%)  0 1/143 (0.70%)  1 0/214 (0.00%)  0
COLONIC POLYP   0/145 (0.00%)  0 0/143 (0.00%)  0 1/214 (0.47%)  1
CONSTIPATION   0/145 (0.00%)  0 0/143 (0.00%)  0 1/214 (0.47%)  1
DIABETIC GASTROPARESIS   1/145 (0.69%)  1 0/143 (0.00%)  0 0/214 (0.00%)  0
DIARRHOEA   0/145 (0.00%)  0 0/143 (0.00%)  0 1/214 (0.47%)  1
DIVERTICULUM INTESTINAL HAEMORRHAGIC   0/145 (0.00%)  0 0/143 (0.00%)  0 3/214 (1.40%)  3
GASTRIC ULCER   0/145 (0.00%)  0 0/143 (0.00%)  0 2/214 (0.93%)  2
GASTRITIS EROSIVE   0/145 (0.00%)  0 0/143 (0.00%)  0 1/214 (0.47%)  1
GASTROINTESTINAL HAEMORRHAGE   1/145 (0.69%)  1 0/143 (0.00%)  0 2/214 (0.93%)  2
INGUINAL HERNIA, OBSTRUCTIVE   0/145 (0.00%)  0 1/143 (0.70%)  1 0/214 (0.00%)  0
NAUSEA   0/145 (0.00%)  0 1/143 (0.70%)  1 0/214 (0.00%)  0
PANCREATITIS   0/145 (0.00%)  0 1/143 (0.70%)  1 1/214 (0.47%)  1
PANCREATITIS ACUTE   0/145 (0.00%)  0 1/143 (0.70%)  1 0/214 (0.00%)  0
PANCREATITIS CHRONIC   0/145 (0.00%)  0 1/143 (0.70%)  2 0/214 (0.00%)  0
PANCREATITIS RELAPSING   0/145 (0.00%)  0 0/143 (0.00%)  0 1/214 (0.47%)  1
SMALL INTESTINAL OBSTRUCTION   0/145 (0.00%)  0 0/143 (0.00%)  0 1/214 (0.47%)  1
SMALL INTESTINAL PERFORATION   0/145 (0.00%)  0 0/143 (0.00%)  0 1/214 (0.47%)  1
UPPER GASTROINTESTINAL HAEMORRHAGE   0/145 (0.00%)  0 0/143 (0.00%)  0 2/214 (0.93%)  2
VOMITING   1/145 (0.69%)  1 1/143 (0.70%)  1 0/214 (0.00%)  0
General disorders       
ADVERSE DRUG REACTION   0/145 (0.00%)  0 1/143 (0.70%)  1 0/214 (0.00%)  0
CATHETER SITE HAEMORRHAGE   0/145 (0.00%)  0 0/143 (0.00%)  0 2/214 (0.93%)  2
CHEST PAIN   0/145 (0.00%)  0 0/143 (0.00%)  0 1/214 (0.47%)  1
DEATH   0/145 (0.00%)  0 1/143 (0.70%)  1 0/214 (0.00%)  0
GENERAL PHYSICAL HEALTH DETERIORATION   0/145 (0.00%)  0 1/143 (0.70%)  1 0/214 (0.00%)  0
MALAISE   0/145 (0.00%)  0 1/143 (0.70%)  2 0/214 (0.00%)  0
NON-CARDIAC CHEST PAIN   2/145 (1.38%)  2 2/143 (1.40%)  2 6/214 (2.80%)  6
PYREXIA   0/145 (0.00%)  0 1/143 (0.70%)  1 0/214 (0.00%)  0
SUDDEN DEATH   1/145 (0.69%)  1 1/143 (0.70%)  1 0/214 (0.00%)  0
Hepatobiliary disorders       
BILIARY COLIC   0/145 (0.00%)  0 1/143 (0.70%)  1 0/214 (0.00%)  0
CHOLELITHIASIS   0/145 (0.00%)  0 0/143 (0.00%)  0 1/214 (0.47%)  1
Infections and infestations       
APPENDICITIS   0/145 (0.00%)  0 0/143 (0.00%)  0 1/214 (0.47%)  1
ARTERIOVENOUS FISTULA SITE INFECTION   1/145 (0.69%)  1 0/143 (0.00%)  0 0/214 (0.00%)  0
ARTERIOVENOUS GRAFT SITE INFECTION   2/145 (1.38%)  2 0/143 (0.00%)  0 1/214 (0.47%)  1
BACTERAEMIA   0/145 (0.00%)  0 0/143 (0.00%)  0 2/214 (0.93%)  2
BRONCHITIS   1/145 (0.69%)  1 0/143 (0.00%)  0 0/214 (0.00%)  0
BRONCHOPNEUMONIA   0/145 (0.00%)  0 1/143 (0.70%)  1 0/214 (0.00%)  0
CELLULITIS   0/145 (0.00%)  0 1/143 (0.70%)  1 4/214 (1.87%)  4
DEVICE RELATED SEPSIS   0/145 (0.00%)  0 2/143 (1.40%)  2 3/214 (1.40%)  3
DIABETIC FOOT INFECTION   0/145 (0.00%)  0 3/143 (2.10%)  4 2/214 (0.93%)  2
GANGRENE   0/145 (0.00%)  0 0/143 (0.00%)  0 5/214 (2.34%)  6
GASTROENTERITIS VIRAL   0/145 (0.00%)  0 1/143 (0.70%)  1 0/214 (0.00%)  0
INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE   0/145 (0.00%)  0 0/143 (0.00%)  0 1/214 (0.47%)  1
INFLUENZA   1/145 (0.69%)  1 0/143 (0.00%)  0 0/214 (0.00%)  0
JOINT ABSCESS   0/145 (0.00%)  0 0/143 (0.00%)  0 1/214 (0.47%)  1
KLEBSIELLA SEPSIS   1/145 (0.69%)  1 0/143 (0.00%)  0 0/214 (0.00%)  0
LOBAR PNEUMONIA   1/145 (0.69%)  1 1/143 (0.70%)  1 1/214 (0.47%)  1
NECROTISING FASCIITIS   0/145 (0.00%)  0 0/143 (0.00%)  0 1/214 (0.47%)  1
OSTEOMYELITIS   1/145 (0.69%)  1 1/143 (0.70%)  1 3/214 (1.40%)  5
PNEUMONIA   3/145 (2.07%)  3 2/143 (1.40%)  2 4/214 (1.87%)  5
POSTOPERATIVE WOUND INFECTION   0/145 (0.00%)  0 1/143 (0.70%)  1 1/214 (0.47%)  1
PSEUDOMONAL BACTERAEMIA   1/145 (0.69%)  1 0/143 (0.00%)  0 0/214 (0.00%)  0
PYELONEPHRITIS ACUTE   1/145 (0.69%)  1 0/143 (0.00%)  0 1/214 (0.47%)  1
SEPSIS   0/145 (0.00%)  0 1/143 (0.70%)  1 1/214 (0.47%)  1
SEPSIS SYNDROME   0/145 (0.00%)  0 0/143 (0.00%)  0 1/214 (0.47%)  1
SEPTIC SHOCK   0/145 (0.00%)  0 1/143 (0.70%)  1 1/214 (0.47%)  1
STAPHYLOCOCCAL BACTERAEMIA   0/145 (0.00%)  0 0/143 (0.00%)  0 2/214 (0.93%)  2
URINARY TRACT INFECTION   0/145 (0.00%)  0 1/143 (0.70%)  1 1/214 (0.47%)  1
UROSEPSIS   0/145 (0.00%)  0 1/143 (0.70%)  1 1/214 (0.47%)  1
VIRAL UPPER RESPIRATORY TRACT INFECTION   0/145 (0.00%)  0 1/143 (0.70%)  1 0/214 (0.00%)  0
Injury, poisoning and procedural complications       
ANAEMIA POSTOPERATIVE   0/145 (0.00%)  0 1/143 (0.70%)  1 1/214 (0.47%)  1
ANKLE FRACTURE   0/145 (0.00%)  0 0/143 (0.00%)  0 1/214 (0.47%)  1
ARTERIOVENOUS FISTULA SITE COMPLICATION   2/145 (1.38%)  2 0/143 (0.00%)  0 0/214 (0.00%)  0
ARTERIOVENOUS FISTULA THROMBOSIS   1/145 (0.69%)  1 3/143 (2.10%)  3 4/214 (1.87%)  4
ARTERIOVENOUS GRAFT SITE HAEMORRHAGE   0/145 (0.00%)  0 1/143 (0.70%)  1 0/214 (0.00%)  0
FACIAL BONES FRACTURE   0/145 (0.00%)  0 0/143 (0.00%)  0 1/214 (0.47%)  1
FALL   1/145 (0.69%)  1 0/143 (0.00%)  0 0/214 (0.00%)  0
FEMORAL NECK FRACTURE   0/145 (0.00%)  0 0/143 (0.00%)  0 1/214 (0.47%)  1
FRACTURE DISPLACEMENT   0/145 (0.00%)  0 0/143 (0.00%)  0 1/214 (0.47%)  2
GASTROINTESTINAL STOMA COMPLICATION   0/145 (0.00%)  0 0/143 (0.00%)  0 1/214 (0.47%)  1
INCISION SITE PAIN   0/145 (0.00%)  0 0/143 (0.00%)  0 1/214 (0.47%)  1
POSTOPERATIVE ILEUS   0/145 (0.00%)  0 0/143 (0.00%)  0 2/214 (0.93%)  2
PROCEDURAL HYPOTENSION   1/145 (0.69%)  1 1/143 (0.70%)  1 4/214 (1.87%)  5
PROCEDURAL NAUSEA   0/145 (0.00%)  0 0/143 (0.00%)  0 1/214 (0.47%)  1
PROCEDURAL PAIN   0/145 (0.00%)  0 2/143 (1.40%)  2 0/214 (0.00%)  0
VASCULAR GRAFT COMPLICATION   0/145 (0.00%)  0 0/143 (0.00%)  0 1/214 (0.47%)  1
VASCULAR GRAFT THROMBOSIS   0/145 (0.00%)  0 1/143 (0.70%)  1 0/214 (0.00%)  0
VASCULAR PSEUDOANEURYSM   0/145 (0.00%)  0 1/143 (0.70%)  1 0/214 (0.00%)  0
Investigations       
TROPONIN INCREASED   1/145 (0.69%)  1 0/143 (0.00%)  0 0/214 (0.00%)  0
Metabolism and nutrition disorders       
DIABETIC FOOT   0/145 (0.00%)  0 1/143 (0.70%)  1 0/214 (0.00%)  0
DIABETIC KETOACIDOSIS   1/145 (0.69%)  1 0/143 (0.00%)  0 1/214 (0.47%)  2
FLUID OVERLOAD   3/145 (2.07%)  5 3/143 (2.10%)  3 10/214 (4.67%)  12
HYPERKALAEMIA   2/145 (1.38%)  2 2/143 (1.40%)  2 7/214 (3.27%)  9
HYPERVOLAEMIA   1/145 (0.69%)  1 0/143 (0.00%)  0 0/214 (0.00%)  0
HYPOGLYCAEMIA   0/145 (0.00%)  0 0/143 (0.00%)  0 4/214 (1.87%)  4
HYPOKALAEMIA   0/145 (0.00%)  0 1/143 (0.70%)  1 0/214 (0.00%)  0
METABOLIC ACIDOSIS   0/145 (0.00%)  0 0/143 (0.00%)  0 1/214 (0.47%)  1
NEUROGLYCOPENIA   0/145 (0.00%)  0 0/143 (0.00%)  0 1/214 (0.47%)  1
Musculoskeletal and connective tissue disorders       
ARTHRITIS   0/145 (0.00%)  0 1/143 (0.70%)  1 0/214 (0.00%)  0
CERVICAL SPINAL STENOSIS   0/145 (0.00%)  0 0/143 (0.00%)  0 1/214 (0.47%)  1
INTERVERTEBRAL DISC PROTRUSION   0/145 (0.00%)  0 1/143 (0.70%)  1 0/214 (0.00%)  0
MUSCULOSKELETAL CHEST PAIN   1/145 (0.69%)  1 0/143 (0.00%)  0 1/214 (0.47%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
BASAL CELL CARCINOMA   0/145 (0.00%)  0 1/143 (0.70%)  1 0/214 (0.00%)  0
CARDIAC NEOPLASM UNSPECIFIED   0/145 (0.00%)  0 0/143 (0.00%)  0 1/214 (0.47%)  1
COLON CANCER   0/145 (0.00%)  0 0/143 (0.00%)  0 1/214 (0.47%)  1
METASTATIC NEOPLASM   0/145 (0.00%)  0 0/143 (0.00%)  0 1/214 (0.47%)  1
PROSTATE CANCER   0/145 (0.00%)  0 0/143 (0.00%)  0 1/214 (0.47%)  1
SQUAMOUS CELL CARCINOMA OF SKIN   0/145 (0.00%)  0 1/143 (0.70%)  1 0/214 (0.00%)  0
TESTIS CANCER   0/145 (0.00%)  0 1/143 (0.70%)  1 0/214 (0.00%)  0
TRANSITIONAL CELL CARCINOMA   0/145 (0.00%)  0 0/143 (0.00%)  0 1/214 (0.47%)  1
Nervous system disorders       
CEREBROVASCULAR ACCIDENT   0/145 (0.00%)  0 1/143 (0.70%)  1 0/214 (0.00%)  0
HYDROCEPHALUS   0/145 (0.00%)  0 1/143 (0.70%)  1 0/214 (0.00%)  0
HYPOXIC-ISCHAEMIC ENCEPHALOPATHY   0/145 (0.00%)  0 0/143 (0.00%)  0 1/214 (0.47%)  1
METABOLIC ENCEPHALOPATHY   0/145 (0.00%)  0 0/143 (0.00%)  0 1/214 (0.47%)  1
POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME   0/145 (0.00%)  0 0/143 (0.00%)  0 1/214 (0.47%)  1
STATUS EPILEPTICUS   0/145 (0.00%)  0 0/143 (0.00%)  0 1/214 (0.47%)  1
SYNCOPE   1/145 (0.69%)  1 0/143 (0.00%)  0 1/214 (0.47%)  1
TRANSIENT ISCHAEMIC ATTACK   0/145 (0.00%)  0 1/143 (0.70%)  1 1/214 (0.47%)  1
VERTEBROBASILAR INSUFFICIENCY   0/145 (0.00%)  0 1/143 (0.70%)  1 0/214 (0.00%)  0
Psychiatric disorders       
ANXIETY   0/145 (0.00%)  0 1/143 (0.70%)  1 0/214 (0.00%)  0
CONFUSIONAL STATE   0/145 (0.00%)  0 1/143 (0.70%)  1 0/214 (0.00%)  0
DEPRESSION   0/145 (0.00%)  0 0/143 (0.00%)  0 1/214 (0.47%)  1
MENTAL STATUS CHANGES   0/145 (0.00%)  0 0/143 (0.00%)  0 2/214 (0.93%)  4
Renal and urinary disorders       
NEPHROLITHIASIS   0/145 (0.00%)  0 0/143 (0.00%)  0 1/214 (0.47%)  1
RENAL CYST HAEMORRHAGE   2/145 (1.38%)  2 0/143 (0.00%)  0 0/214 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
ACUTE PULMONARY OEDEMA   2/145 (1.38%)  2 0/143 (0.00%)  0 0/214 (0.00%)  0
ACUTE RESPIRATORY FAILURE   0/145 (0.00%)  0 0/143 (0.00%)  0 3/214 (1.40%)  3
CHRONIC OBSTRUCTIVE PULMONARY DISEASE   0/145 (0.00%)  0 1/143 (0.70%)  1 2/214 (0.93%)  2
DYSPNOEA   0/145 (0.00%)  0 0/143 (0.00%)  0 1/214 (0.47%)  1
EPISTAXIS   0/145 (0.00%)  0 0/143 (0.00%)  0 1/214 (0.47%)  1
PLEURAL EFFUSION   0/145 (0.00%)  0 0/143 (0.00%)  0 1/214 (0.47%)  1
PULMONARY EMBOLISM   0/145 (0.00%)  0 0/143 (0.00%)  0 1/214 (0.47%)  1
PULMONARY OEDEMA   0/145 (0.00%)  0 4/143 (2.80%)  4 7/214 (3.27%)  7
RESPIRATORY DISTRESS   0/145 (0.00%)  0 0/143 (0.00%)  0 1/214 (0.47%)  1
RESPIRATORY FAILURE   1/145 (0.69%)  1 0/143 (0.00%)  0 1/214 (0.47%)  1
Skin and subcutaneous tissue disorders       
ANGIOEDEMA   0/145 (0.00%)  0 0/143 (0.00%)  0 1/214 (0.47%)  1
DECUBITUS ULCER   0/145 (0.00%)  0 0/143 (0.00%)  0 1/214 (0.47%)  1
SKIN ULCER   1/145 (0.69%)  1 0/143 (0.00%)  0 0/214 (0.00%)  0
URTICARIA   0/145 (0.00%)  0 0/143 (0.00%)  0 1/214 (0.47%)  1
Surgical and medical procedures       
CARDIAC ABLATION   1/145 (0.69%)  1 0/143 (0.00%)  0 0/214 (0.00%)  0
OBESITY SURGERY   0/145 (0.00%)  0 0/143 (0.00%)  0 1/214 (0.47%)  1
REVERSAL OF ILEOJEJUNAL BYPASS   0/145 (0.00%)  0 0/143 (0.00%)  0 1/214 (0.47%)  1
Vascular disorders       
AORTIC DISSECTION   0/145 (0.00%)  0 0/143 (0.00%)  0 1/214 (0.47%)  1
AORTIC STENOSIS   1/145 (0.69%)  1 0/143 (0.00%)  0 0/214 (0.00%)  0
DEEP VEIN THROMBOSIS   1/145 (0.69%)  1 0/143 (0.00%)  0 1/214 (0.47%)  1
EXSANGUINATION   0/145 (0.00%)  0 0/143 (0.00%)  0 1/214 (0.47%)  1
FEMORAL ARTERY OCCLUSION   1/145 (0.69%)  1 0/143 (0.00%)  0 0/214 (0.00%)  0
HYPERTENSION   0/145 (0.00%)  0 1/143 (0.70%)  1 0/214 (0.00%)  0
HYPERTENSIVE CRISIS   0/145 (0.00%)  0 0/143 (0.00%)  0 1/214 (0.47%)  1
HYPERTENSIVE EMERGENCY   0/145 (0.00%)  0 0/143 (0.00%)  0 1/214 (0.47%)  1
HYPOTENSION   1/145 (0.69%)  1 1/143 (0.70%)  1 2/214 (0.93%)  2
MALIGNANT HYPERTENSION   0/145 (0.00%)  0 0/143 (0.00%)  0 2/214 (0.93%)  2
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE   0/145 (0.00%)  0 1/143 (0.70%)  1 0/214 (0.00%)  0
PERIPHERAL VASCULAR DISORDER   0/145 (0.00%)  0 1/143 (0.70%)  1 1/214 (0.47%)  1
TEMPORAL ARTERITIS   0/145 (0.00%)  0 0/143 (0.00%)  0 1/214 (0.47%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3.0%
Stage 2 Standard Dialysate (Placebo) Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate Stage 3 Soluble Ferric Pyrophosphate (SFP)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   93/145 (64.14%)      89/143 (62.24%)      179/214 (83.64%)    
Blood and lymphatic system disorders       
ANAEMIA   5/145 (3.45%)  5 3/143 (2.10%)  3 17/214 (7.94%)  21
Cardiac disorders       
ANGINA PECTORIS   2/145 (1.38%)  3 1/143 (0.70%)  2 11/214 (5.14%)  13
BRADYCARDIA   4/145 (2.76%)  6 4/143 (2.80%)  10 7/214 (3.27%)  15
TACHYCARDIA   4/145 (2.76%)  5 1/143 (0.70%)  14 8/214 (3.74%)  11
Gastrointestinal disorders       
ABDOMINAL DISCOMFORT   2/145 (1.38%)  2 2/143 (1.40%)  4 9/214 (4.21%)  10
ABDOMINAL PAIN   5/145 (3.45%)  5 5/143 (3.50%)  5 7/214 (3.27%)  11
ABDOMINAL PAIN UPPER   4/145 (2.76%)  4 3/143 (2.10%)  3 7/214 (3.27%)  8
CONSTIPATION   2/145 (1.38%)  2 5/143 (3.50%)  5 18/214 (8.41%)  19
DIARRHOEA   12/145 (8.28%)  14 10/143 (6.99%)  12 35/214 (16.36%)  62
DYSPEPSIA   3/145 (2.07%)  3 5/143 (3.50%)  5 6/214 (2.80%)  6
NAUSEA   15/145 (10.34%)  19 11/143 (7.69%)  21 46/214 (21.50%)  74
TOOTHACHE   0/145 (0.00%)  0 3/143 (2.10%)  3 7/214 (3.27%)  10
VOMITING   12/145 (8.28%)  16 11/143 (7.69%)  15 33/214 (15.42%)  46
General disorders       
ASTHENIA   2/145 (1.38%)  2 4/143 (2.80%)  5 17/214 (7.94%)  20
CHILLS   0/145 (0.00%)  0 2/143 (1.40%)  2 8/214 (3.74%)  13
FACE OEDEMA   3/145 (2.07%)  3 2/143 (1.40%)  3 12/214 (5.61%)  15
FATIGUE   4/145 (2.76%)  4 4/143 (2.80%)  4 14/214 (6.54%)  15
NON-CARDIAC CHEST PAIN   4/145 (2.76%)  4 2/143 (1.40%)  2 9/214 (4.21%)  10
OEDEMA PERIPHERAL   3/145 (2.07%)  4 12/143 (8.39%)  14 31/214 (14.49%)  49
PAIN   1/145 (0.69%)  1 1/143 (0.70%)  1 20/214 (9.35%)  26
PYREXIA   5/145 (3.45%)  5 5/143 (3.50%)  5 21/214 (9.81%)  23
THROMBOSIS IN DEVICE   0/145 (0.00%)  0 2/143 (1.40%)  2 8/214 (3.74%)  14
Infections and infestations       
BRONCHITIS   2/145 (1.38%)  2 5/143 (3.50%)  5 4/214 (1.87%)  4
CELLULITIS   1/145 (0.69%)  1 1/143 (0.70%)  1 7/214 (3.27%)  7
NASOPHARYNGITIS   9/145 (6.21%)  11 5/143 (3.50%)  6 11/214 (5.14%)  12
UPPER RESPIRATORY TRACT INFECTION   8/145 (5.52%)  8 8/143 (5.59%)  11 12/214 (5.61%)  16
URINARY TRACT INFECTION   1/145 (0.69%)  1 5/143 (3.50%)  7 6/214 (2.80%)  6
Injury, poisoning and procedural complications       
ARTERIOVENOUS FISTULA SITE COMPLICATION   14/145 (9.66%)  21 15/143 (10.49%)  19 52/214 (24.30%)  85
ARTERIOVENOUS FISTULA SITE HAEMORRHAGE   2/145 (1.38%)  6 6/143 (4.20%)  7 12/214 (5.61%)  18
CONTUSION   6/145 (4.14%)  6 6/143 (4.20%)  6 9/214 (4.21%)  12
FALL   0/145 (0.00%)  0 4/143 (2.80%)  4 7/214 (3.27%)  9
HAEMODIALYSIS-INDUCED SYMPTOM   9/145 (6.21%)  19 10/143 (6.99%)  14 58/214 (27.10%)  183
PROCEDURAL DIZZINESS   2/145 (1.38%)  3 4/143 (2.80%)  7 8/214 (3.74%)  20
PROCEDURAL HEADACHE   1/145 (0.69%)  1 1/143 (0.70%)  1 8/214 (3.74%)  14
PROCEDURAL HYPERTENSION   0/145 (0.00%)  0 1/143 (0.70%)  1 12/214 (5.61%)  26
PROCEDURAL HYPOTENSION   16/145 (11.03%)  67 19/143 (13.29%)  143 75/214 (35.05%)  567
PROCEDURAL NAUSEA   2/145 (1.38%)  4 1/143 (0.70%)  1 13/214 (6.07%)  18
PROCEDURAL PAIN   1/145 (0.69%)  2 3/143 (2.10%)  3 17/214 (7.94%)  20
VASCULAR GRAFT COMPLICATION   4/145 (2.76%)  8 2/143 (1.40%)  3 11/214 (5.14%)  13
VASCULAR GRAFT THROMBOSIS   1/145 (0.69%)  1 0/143 (0.00%)  0 7/214 (3.27%)  8
Metabolism and nutrition disorders       
FLUID OVERLOAD   7/145 (4.83%)  8 5/143 (3.50%)  7 19/214 (8.88%)  45
HYPERKALAEMIA   3/145 (2.07%)  3 5/143 (3.50%)  5 21/214 (9.81%)  21
HYPOGLYCAEMIA   4/145 (2.76%)  5 5/143 (3.50%)  5 7/214 (3.27%)  10
Musculoskeletal and connective tissue disorders       
ARTHRALGIA   5/145 (3.45%)  5 2/143 (1.40%)  2 14/214 (6.54%)  16
BACK PAIN   6/145 (4.14%)  7 6/143 (4.20%)  6 17/214 (7.94%)  20
MUSCLE SPASMS   5/145 (3.45%)  8 8/143 (5.59%)  9 4/214 (1.87%)  6
MUSCULOSKELETAL PAIN   2/145 (1.38%)  2 1/143 (0.70%)  1 8/214 (3.74%)  9
PAIN IN EXTREMITY   9/145 (6.21%)  12 7/143 (4.90%)  7 24/214 (11.21%)  28
Nervous system disorders       
DIZZINESS   8/145 (5.52%)  11 9/143 (6.29%)  19 34/214 (15.89%)  45
HEADACHE   8/145 (5.52%)  9 13/143 (9.09%)  23 40/214 (18.69%)  61
Psychiatric disorders       
ANXIETY   3/145 (2.07%)  3 1/143 (0.70%)  1 7/214 (3.27%)  8
INSOMNIA   5/145 (3.45%)  5 2/143 (1.40%)  2 7/214 (3.27%)  7
Respiratory, thoracic and mediastinal disorders       
COUGH   14/145 (9.66%)  15 10/143 (6.99%)  13 18/214 (8.41%)  23
DYSPNOEA   6/145 (4.14%)  6 11/143 (7.69%)  11 28/214 (13.08%)  36
DYSPNOEA EXERTIONAL   1/145 (0.69%)  2 2/143 (1.40%)  2 8/214 (3.74%)  10
NASAL CONGESTION   1/145 (0.69%)  1 1/143 (0.70%)  1 7/214 (3.27%)  7
OROPHARYNGEAL PAIN   0/145 (0.00%)  0 2/143 (1.40%)  2 7/214 (3.27%)  11
Skin and subcutaneous tissue disorders       
PRURITUS   1/145 (0.69%)  1 2/143 (1.40%)  2 10/214 (4.67%)  10
Vascular disorders       
HYPERTENSION   5/145 (3.45%)  5 5/143 (3.50%)  6 8/214 (3.74%)  8
HYPOTENSION   4/145 (2.76%)  5 5/143 (3.50%)  5 10/214 (4.67%)  11
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Director, Clinical Research & Development
Organization: Rockwell Medical
Phone: 248-960-9009
EMail: rd@rockwellmed.com
Layout table for additonal information
Responsible Party: Rockwell Medical Technologies, Inc.
ClinicalTrials.gov Identifier: NCT01322347     History of Changes
Other Study ID Numbers: RMTI-SFP-5
First Submitted: March 22, 2011
First Posted: March 24, 2011
Results First Submitted: March 20, 2015
Results First Posted: April 24, 2015
Last Update Posted: April 26, 2017