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Trial record 70 of 380 for:    FERRIC CATION

Continuous Soluble Ferric Pyrophosphate (SFP) Iron Delivery Via Dialysate in Hemodialysis Patients (CRUISE 1)

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ClinicalTrials.gov Identifier: NCT01320202
Recruitment Status : Completed
First Posted : March 22, 2011
Results First Posted : April 28, 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 305
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Soluble Ferric Pyrophosphate (SFP) in Dialysate 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.

Period Title: Overall Study
Started 152 153
Comp 48 Wks in St 2 27 27
Comp St 2 Due to ESA/IV Iron Needs 69 82
Enrolled in St 3 98 109
Completed St 3 79 82
Completed 96 109
Not Completed 56 44
Reason Not Completed
Adverse Event             5             5
Death             5             3
Lost to Follow-up             1             0
Physician Decision             3             1
Protocol Violation             2             1
Withdrawal by Subject             10             3
non-protocol change to ESA or IV iron             17             20
kidney transplant             1             2
blood transfusion             1             7
moved/changed dialysis             5             2
sponsor request             2             0
ineligible             3             0
regained renal function             1             0
Arm/Group Title Soluble Ferric Pyrophosphate (SFP) in Dialysate Standard Dialysate 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 18 months.

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 18 months.

Total of all reporting groups
Overall Number of Baseline Participants 152 153 305
Hide Baseline Analysis Population Description
Intent-to-treat population: all randomized subjects, regardless of whether they received any investigational product.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 152 participants 153 participants 305 participants
56.6  (12.56) 59.9  (13.01) 58.3  (12.87)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 152 participants 153 participants 305 participants
Female
50
  32.9%
48
  31.4%
98
  32.1%
Male
102
  67.1%
105
  68.6%
207
  67.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 152 participants 153 participants 305 participants
Hispanic or Latino
74
  48.7%
65
  42.5%
139
  45.6%
Not Hispanic or Latino
78
  51.3%
88
  57.5%
166
  54.4%
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 152 participants 153 participants 305 participants
American Indian or Alaska Native
6
   3.9%
12
   7.8%
18
   5.9%
Asian
8
   5.3%
5
   3.3%
13
   4.3%
Native Hawaiian or Other Pacific Islander
2
   1.3%
0
   0.0%
2
   0.7%
Black or African American
50
  32.9%
48
  31.4%
98
  32.1%
White
84
  55.3%
84
  54.9%
168
  55.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
2
   1.3%
4
   2.6%
6
   2.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 152 participants 153 participants 305 participants
United States 145 143 288
Puerto Rico 7 10 17
post-dialysis body weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 152 participants 153 participants 305 participants
84.08  (23.264) 83.15  (22.166) 83.61  (22.685)
height  
Mean (Standard Deviation)
Unit of measure:  Centimeters
Number Analyzed 152 participants 153 participants 305 participants
168.48  (10.197) 169.17  (9.350) 168.82  (9.771)
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 with standard error.
Time Frame Hgb measured weekly; up to 48 weeks from the date of randomization
Hide Outcome Measure Data
Hide Analysis Population Description
modified intent-to-treat populations: all randomized subjects who received at least one dose of study medication and had at least one post-dose hemoglobin measurement obtained.
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 148 151
Least Squares Mean (Standard Error)
Unit of Measure: grams per liter
0.6  (1.15) -3.0  (1.14)
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: 1.40
Estimation Comments [Not Specified]
2.Primary Outcome
Title Change From Baseline Hemoglobin at End-of-Treatment: Mean Baseline and End-of-Treatment Hgb
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 the date of randomization
Hide Outcome Measure Data
Hide Analysis Population Description
modified intent-to-treat: all randomized patients 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 in Stage 2.

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 in Stage 2.

Overall Number of Participants Analyzed 148 151
Mean (Standard Deviation)
Unit of Measure: grams per liter
mean baseline hemoglobin 109.6  (5.91) 109.0  (6.36)
mean end-of-treatment hemoglobin 109.1  (12.53) 105.2  (13.65)
mean change in Hemoglobin at end-of-treatment -0.4  (11.67) -3.9  (12.52)
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 the date of randomization
Hide Outcome Measure Data
Hide Analysis Population Description
modified intent-to-treat population: 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 148 151
Mean (Standard Deviation)
Unit of Measure: micromoles per liter
mean pre-dialysis serum iron 12.1  (4.15) 10.8  (3.04)
mean post-dialysis serum iron 29.6  (8.64) 11.5  (3.91)
serum iron change from pre- to post-dialysis 17.5  (8.70) 0.6  (3.08)
4.Secondary Outcome
Title Mean Change in TSAT (Transferrin) 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 the date of randomization
Hide Outcome Measure Data
Hide Analysis Population Description
modified intent-to treat: all randomized subjects who had 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 148 151
Mean (Standard Deviation)
Unit of Measure: percent
mean pre-dialysis TSAT(transferrin) 24.9  (6.86) 22.4  (5.97)
mean post-dialysis TSAT(transferrin) 57.9  (15.94) 22.2  (7.80)
pre- to post-dialysis change in TSAT 32.7  (15.83) -0.4  (6.86)
5.Secondary Outcome
Title Mean Change in Unsaturated Iron Binding Capacity (UIBC) From Pre- 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 the 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 148 151
Mean (Standard Deviation)
Unit of Measure: micromole per liter
mean pre-dialysis UIBC 31.49  (6.797) 32.27  (6.580)
mean post-dialysis UIBC 19.48  (7.911) 34.51  (7.208)
pre- to post-dialysis change in UIBC -11.86  (6.604) 2.38  (3.253)
6.Secondary Outcome
Title Red Blood Cell or Whole Blood Transfusion: Number of Patients Receiving 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 the date of randomization
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT): all patients randomized are included.
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 in Stage 2.

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 in Stage 2.

Overall Number of Participants Analyzed 152 153
Measure Type: Number
Unit of Measure: participants
3 11
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 the date of randomization
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT): all patients randomized are included.
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 in Stage 2.

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 in Stage 2.

Overall Number of Participants Analyzed 152 153
Measure Type: Number
Unit of Measure: units of red blood cells or whole blood
5 19
8.Secondary Outcome
Title Percentage of Change From Baseline to End-of-Treatment (EoT) for: Reticulocyte Hemoglobin Content (CHr), Ferritin, and 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 the 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 in Stage 2.

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 in Stage 2.

Overall Number of Participants Analyzed 148 151
Mean (Standard Deviation)
Unit of Measure: percentage of change
CHr: % of change from baseline -0.64  (3.800) -2.73  (4.289)
Ferritin: % of change from baseline -14.8  (27.68) -28.5  (34.35)
Pre-dialysis UIBC: % of change from baseline 8.36  (53.186) 7.62  (14.818)
Pre-dialysis serum iron: % of change from baseline 4.644  (53.1728) -4.628  (29.0307)
Pre-dialysis transferrin: % change from baseline 1.718  (8.5133) 2.633  (9.7691)
Pre-dialysis TIBC: % of change from baseline 1.80  (9.255) 2.88  (10.253)
Pre-dialysis TSAT: % of change from baseline 1.8  (44.99) -7.8  (26.42)
9.Secondary Outcome
Title Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Unsaturated Iron-Binding Capacity (UIBC), Serum Iron, and 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 the 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 in Stage 2.

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 in Stage 2.

Overall Number of Participants Analyzed 148 151
Mean (Standard Deviation)
Unit of Measure: micromoles per liter
Baseline UIBC 30.91  (6.784) 30.77  (6.452)
EoT UIBC 32.76  (13.734) 33.03  (7.527)
UIBC: Change from Baseline to EoT 1.93  (13.265) 2.14  (4.447)
Baseline Serum Iron 11.976  (3.9192) 11.443  (3.9198)
EoT Serum Iron 11.911  (4.5412) 10.389  (3.4941)
Serum Iron: Change from Baseline to EoT -0.196  (4.7462) -1.051  (3.6562)
Baseline TIBC 42.88  (7.458) 42.22  (7.380)
EoT TIBC 43.59  (8.140) 43.40  (7.964)
TIBC: Change from Baseline to EoT 0.65  (4.051) 1.08  (4.296)
10.Secondary Outcome
Title Change From Baseline to End-of-Treatment (EoT) in Reticulocyte Hemoglobin Content (CHr)
Hide Description The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Reticulocyte Hemoglobin Content (CHr) will be quantified.
Time Frame Up to 48 weeks from the 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 in Stage 2.

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 in Stage 2.

Overall Number of Participants Analyzed 148 151
Mean (Standard Deviation)
Unit of Measure: picograms
Baseline CHr 32.37  (1.985) 32.57  (1.953)
EoT CHr 32.12  (2.016) 31.64  (2.019)
CHr: Change from Baseline to EoT -0.23  (1.203) -0.91  (1.413)
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 will be quantified.
Time Frame Up to 48 weeks from the 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 in Stage 2.

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 in Stage 2.

Overall Number of Participants Analyzed 148 151
Mean (Standard Deviation)
Unit of Measure: micrograms per liter
Baseline Ferritin 509.6  (194.16) 511.3  (209.68)
EoT Ferritin 440.7  (216.41) 366.9  (224.01)
Ferritin: Change from Baseline to EoT -72.3  (133.40) -143.1  (188.28)
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 will be quantified.
Time Frame Up to 48 weeks from the 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 in Stage 2.

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 in Stage 2.

Overall Number of Participants Analyzed 148 151
Mean (Standard Deviation)
Unit of Measure: grams per liter
Baseline Pre-Dialysis Transferrin 1.928  (0.3427) 1.908  (0.3475)
EoT Pre-Dialysis Transferrin 1.958  (0.3767) 1.957  (0.3731)
Pre-Dialysis Ferritin: Change from Baseline to EoT 0.029  (0.1695) 0.044  (0.1883)
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) will be quantified.
Time Frame Up to 48 weeks from the 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 in Stage 2.

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 in Stage 2.

Overall Number of Participants Analyzed 148 151
Mean (Standard Deviation)
Unit of Measure: percentage of saturation
Baseline Pre-Dialysis TSAT 28.1  (8.13) 27.1  (7.79)
EoT Pre-Dialysis TSAT 27.3  (8.52) 24.0  (7.44)
Pre-Dialysis TSAT: Change from Baseline to EoT -1.1  (9.16) -3.0  (7.70)
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 Hgb measured weekly; up to 48 weeks from the 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)
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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 148 151
Mean (Standard Deviation)
Unit of Measure: grams per liter per week
0.060  (0.298) 0.002  (0.235)
15.Secondary Outcome
Title Variability of Hemoglobin Concentration: Residual Standard Deviation
Hide Description The mean residual standard deviation of hemoglobin concentration value changes, as measured weekly from baseline until the end of participation in Stage 2.
Time Frame Hgb measured weekly; up to 48 weeks from the 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 148 151
Mean (Standard Deviation)
Unit of Measure: grams per liter
4.104  (2.220) 4.588  (1.949)
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 = 300, which is 5 patients fewer than the number of patients randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Five subjects withdrew from Stage 2 and 2 subjects withdrew from Stage 3 prior to exposure.
 
Arm/Group Title Stage 2 Placebo (Standard Dialysate) Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate Stage 3 Soluble Ferric Pyrophosphate (SFP) in Dialysate
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 Placebo (Standard Dialysate) Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate Stage 3 Soluble Ferric Pyrophosphate (SFP) in Dialysate
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Stage 2 Placebo (Standard Dialysate) Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate Stage 3 Soluble Ferric Pyrophosphate (SFP) in Dialysate
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   45/151 (29.80%)      36/149 (24.16%)      81/205 (39.51%)    
Blood and lymphatic system disorders       
ANAEMIA   1/151 (0.66%)  1 1/149 (0.67%)  1 1/205 (0.49%)  1
ANAEMIA OF CHRONIC DISEASE   1/151 (0.66%)  1 0/149 (0.00%)  0 0/205 (0.00%)  0
THROMBOCYTOPENIA   0/151 (0.00%)  0 0/149 (0.00%)  0 1/205 (0.49%)  1
Cardiac disorders       
ACUTE MYOCARDIAL INFARCTION   3/151 (1.99%)  3 3/149 (2.01%)  3 1/205 (0.49%)  1
ANGINA PECTORIS   0/151 (0.00%)  0 1/149 (0.67%)  1 3/205 (1.46%)  3
ANGINA UNSTABLE   0/151 (0.00%)  0 1/149 (0.67%)  1 0/205 (0.00%)  0
ATRIAL FIBRILLATION   1/151 (0.66%)  1 0/149 (0.00%)  0 3/205 (1.46%)  3
ATRIAL FLUTTER   1/151 (0.66%)  2 0/149 (0.00%)  0 1/205 (0.49%)  1
ATRIOVENTRICULAR BLOCK FIRST DEGREE   1/151 (0.66%)  1 0/149 (0.00%)  0 0/205 (0.00%)  0
ATRIOVENTRICULAR BLOCK SECOND DEGREE   0/151 (0.00%)  0 0/149 (0.00%)  0 1/205 (0.49%)  1
CARDIAC ARREST   1/151 (0.66%)  1 2/149 (1.34%)  2 5/205 (2.44%)  5
CARDIAC FAILURE CONGESTIVE   5/151 (3.31%)  8 1/149 (0.67%)  2 4/205 (1.95%)  8
CARDIOGENIC SHOCK   0/151 (0.00%)  0 0/149 (0.00%)  0 1/205 (0.49%)  1
CARDIOMYOPATHY   1/151 (0.66%)  1 0/149 (0.00%)  0 0/205 (0.00%)  0
CARDIO-RESPIRATORY ARREST   2/151 (1.32%)  2 0/149 (0.00%)  0 2/205 (0.98%)  2
CONGESTIVE CARDIOMYOPATHY   0/151 (0.00%)  0 0/149 (0.00%)  0 1/205 (0.49%)  1
CORONARY ARTERY DISEASE   1/151 (0.66%)  1 2/149 (1.34%)  2 3/205 (1.46%)  3
INTRACARDIAC THROMBUS   0/151 (0.00%)  0 0/149 (0.00%)  0 1/205 (0.49%)  1
MYOCARDIAL INFARCTION   1/151 (0.66%)  1 0/149 (0.00%)  0 1/205 (0.49%)  1
SUPRAVENTRICULAR TACHYCARDIA   1/151 (0.66%)  1 0/149 (0.00%)  0 0/205 (0.00%)  0
Endocrine disorders       
HYPERPARATHYROIDISM SECONDARY   0/151 (0.00%)  0 0/149 (0.00%)  0 2/205 (0.98%)  2
Gastrointestinal disorders       
ABDOMINAL PAIN   0/151 (0.00%)  0 1/149 (0.67%)  1 0/205 (0.00%)  0
CROHN'S DISEASE   0/151 (0.00%)  0 0/149 (0.00%)  0 1/205 (0.49%)  1
DIARRHOEA   2/151 (1.32%)  2 1/149 (0.67%)  1 0/205 (0.00%)  0
DIVERTICULUM INTESTINAL HAEMORRHAGIC   0/151 (0.00%)  0 0/149 (0.00%)  0 1/205 (0.49%)  1
DYSPHAGIA   1/151 (0.66%)  1 0/149 (0.00%)  0 0/205 (0.00%)  0
GASTRITIS   1/151 (0.66%)  1 0/149 (0.00%)  0 2/205 (0.98%)  2
GASTRITIS EROSIVE   0/151 (0.00%)  0 1/149 (0.67%)  1 1/205 (0.49%)  1
GASTROINTESTINAL HAEMORRHAGE   1/151 (0.66%)  1 0/149 (0.00%)  0 1/205 (0.49%)  1
GASTROOESOPHAGEAL REFLUX DISEASE   1/151 (0.66%)  1 0/149 (0.00%)  0 3/205 (1.46%)  3
LOWER GASTROINTESTINAL HAEMORRHAGE   0/151 (0.00%)  0 0/149 (0.00%)  0 1/205 (0.49%)  1
NAUSEA   1/151 (0.66%)  1 0/149 (0.00%)  0 1/205 (0.49%)  1
OESOPHAGEAL ULCER HAEMORRHAGE   1/151 (0.66%)  1 0/149 (0.00%)  0 0/205 (0.00%)  0
PANCREATITIS   0/151 (0.00%)  0 0/149 (0.00%)  0 1/205 (0.49%)  1
PANCREATITIS ACUTE   0/151 (0.00%)  0 0/149 (0.00%)  0 1/205 (0.49%)  1
PORTAL HYPERTENSIVE GASTROPATHY   0/151 (0.00%)  0 1/149 (0.67%)  1 0/205 (0.00%)  0
SMALL INTESTINAL OBSTRUCTION   0/151 (0.00%)  0 0/149 (0.00%)  0 1/205 (0.49%)  1
VOMITING   1/151 (0.66%)  1 0/149 (0.00%)  0 0/205 (0.00%)  0
General disorders       
ADVERSE DRUG REACTION   0/151 (0.00%)  0 0/149 (0.00%)  0 1/205 (0.49%)  1
CATHETER SITE HAEMATOMA   0/151 (0.00%)  0 0/149 (0.00%)  0 1/205 (0.49%)  1
CHEST PAIN   0/151 (0.00%)  0 0/149 (0.00%)  0 1/205 (0.49%)  1
CHILLS   0/151 (0.00%)  0 1/149 (0.67%)  1 0/205 (0.00%)  0
DEATH   0/151 (0.00%)  0 1/149 (0.67%)  1 0/205 (0.00%)  0
DEVICE DISLOCATION   0/151 (0.00%)  0 0/149 (0.00%)  0 1/205 (0.49%)  1
NON-CARDIAC CHEST PAIN   5/151 (3.31%)  5 1/149 (0.67%)  1 3/205 (1.46%)  3
PYREXIA   0/151 (0.00%)  0 0/149 (0.00%)  0 1/205 (0.49%)  1
STENT-GRAFT ENDOLEAK   0/151 (0.00%)  0 0/149 (0.00%)  0 1/205 (0.49%)  1
SUDDEN DEATH   0/151 (0.00%)  0 1/149 (0.67%)  1 0/205 (0.00%)  0
Hepatobiliary disorders       
CHOLANGITIS   1/151 (0.66%)  1 0/149 (0.00%)  0 0/205 (0.00%)  0
Infections and infestations       
ARTERIOVENOUS GRAFT SITE INFECTION   0/151 (0.00%)  0 0/149 (0.00%)  0 1/205 (0.49%)  1
BACTERAEMIA   1/151 (0.66%)  1 0/149 (0.00%)  0 1/205 (0.49%)  1
CELLULITIS   1/151 (0.66%)  1 1/149 (0.67%)  1 2/205 (0.98%)  2
CLOSTRIDIUM DIFFICILE COLITIS   0/151 (0.00%)  0 0/149 (0.00%)  0 1/205 (0.49%)  1
DEVICE RELATED INFECTION   1/151 (0.66%)  1 0/149 (0.00%)  0 0/205 (0.00%)  0
DIVERTICULITIS   1/151 (0.66%)  1 0/149 (0.00%)  0 0/205 (0.00%)  0
ENDOCARDITIS   0/151 (0.00%)  0 0/149 (0.00%)  0 1/205 (0.49%)  1
GANGRENE   0/151 (0.00%)  0 0/149 (0.00%)  0 1/205 (0.49%)  1
GASTROENTERITIS   0/151 (0.00%)  0 0/149 (0.00%)  0 3/205 (1.46%)  3
GASTROENTERITIS VIRAL   1/151 (0.66%)  1 0/149 (0.00%)  0 0/205 (0.00%)  0
INFECTED SKIN ULCER   0/151 (0.00%)  0 0/149 (0.00%)  0 1/205 (0.49%)  1
LOBAR PNEUMONIA   0/151 (0.00%)  0 1/149 (0.67%)  1 0/205 (0.00%)  0
OSTEOMYELITIS   0/151 (0.00%)  0 0/149 (0.00%)  0 2/205 (0.98%)  2
PNEUMONIA   5/151 (3.31%)  5 4/149 (2.68%)  4 5/205 (2.44%)  10
RENAL CYST INFECTION   1/151 (0.66%)  1 0/149 (0.00%)  0 0/205 (0.00%)  0
SEPSIS   0/151 (0.00%)  0 1/149 (0.67%)  1 4/205 (1.95%)  4
STAPHYLOCOCCAL BACTERAEMIA   0/151 (0.00%)  0 0/149 (0.00%)  0 3/205 (1.46%)  3
UPPER RESPIRATORY TRACT INFECTION   2/151 (1.32%)  2 0/149 (0.00%)  0 0/205 (0.00%)  0
URINARY TRACT INFECTION   1/151 (0.66%)  1 1/149 (0.67%)  1 2/205 (0.98%)  2
UROSEPSIS   0/151 (0.00%)  0 0/149 (0.00%)  0 1/205 (0.49%)  1
VIRAL INFECTION   0/151 (0.00%)  0 0/149 (0.00%)  0 1/205 (0.49%)  1
Injury, poisoning and procedural complications       
ANAEMIA POSTOPERATIVE   0/151 (0.00%)  0 0/149 (0.00%)  0 1/205 (0.49%)  1
ARTERIOVENOUS FISTULA ANEURYSM   0/151 (0.00%)  0 1/149 (0.67%)  1 0/205 (0.00%)  0
ARTERIOVENOUS FISTULA OCCLUSION   0/151 (0.00%)  0 0/149 (0.00%)  0 1/205 (0.49%)  1
ARTERIOVENOUS FISTULA SITE COMPLICATION   0/151 (0.00%)  0 0/149 (0.00%)  0 1/205 (0.49%)  1
ARTERIOVENOUS FISTULA SITE HAEMATOMA   0/151 (0.00%)  0 1/149 (0.67%)  1 0/205 (0.00%)  0
ARTERIOVENOUS FISTULA SITE HAEMORRHAGE   0/151 (0.00%)  0 1/149 (0.67%)  1 1/205 (0.49%)  1
ARTERIOVENOUS FISTULA THROMBOSIS   1/151 (0.66%)  1 2/149 (1.34%)  2 4/205 (1.95%)  4
COMMINUTED FRACTURE   0/151 (0.00%)  0 0/149 (0.00%)  0 1/205 (0.49%)  1
FACIAL BONES FRACTURE   1/151 (0.66%)  1 1/149 (0.67%)  1 0/205 (0.00%)  0
HEAD INJURY   1/151 (0.66%)  1 0/149 (0.00%)  0 1/205 (0.49%)  1
HIP FRACTURE   1/151 (0.66%)  1 0/149 (0.00%)  0 0/205 (0.00%)  0
MUSCLE RUPTURE   1/151 (0.66%)  1 0/149 (0.00%)  0 0/205 (0.00%)  0
MUSCLE STRAIN   0/151 (0.00%)  0 1/149 (0.67%)  1 0/205 (0.00%)  0
POST PROCEDURAL HAEMATOMA   0/151 (0.00%)  0 0/149 (0.00%)  0 1/205 (0.49%)  1
PROCEDURAL HYPERTENSION   0/151 (0.00%)  0 0/149 (0.00%)  0 1/205 (0.49%)  1
PROCEDURAL HYPOTENSION   0/151 (0.00%)  0 0/149 (0.00%)  0 2/205 (0.98%)  2
ROAD TRAFFIC ACCIDENT   0/151 (0.00%)  0 0/149 (0.00%)  0 1/205 (0.49%)  1
VASCULAR GRAFT THROMBOSIS   1/151 (0.66%)  1 0/149 (0.00%)  0 4/205 (1.95%)  6
Metabolism and nutrition disorders       
DECREASED APPETITE   0/151 (0.00%)  0 0/149 (0.00%)  0 1/205 (0.49%)  1
DEHYDRATION   0/151 (0.00%)  0 0/149 (0.00%)  0 1/205 (0.49%)  1
DIABETES MELLITUS INADEQUATE CONTROL   0/151 (0.00%)  0 1/149 (0.67%)  1 0/205 (0.00%)  0
DIABETIC FOOT   0/151 (0.00%)  0 0/149 (0.00%)  0 1/205 (0.49%)  1
FLUID OVERLOAD   10/151 (6.62%)  12 2/149 (1.34%)  2 5/205 (2.44%)  5
HYPERGLYCAEMIA   2/151 (1.32%)  2 0/149 (0.00%)  0 0/205 (0.00%)  0
HYPERKALAEMIA   4/151 (2.65%)  7 0/149 (0.00%)  0 9/205 (4.39%)  11
HYPOGLYCAEMIA   0/151 (0.00%)  0 0/149 (0.00%)  0 2/205 (0.98%)  2
HYPOVOLAEMIA   0/151 (0.00%)  0 0/149 (0.00%)  0 2/205 (0.98%)  2
Musculoskeletal and connective tissue disorders       
BACK PAIN   0/151 (0.00%)  0 1/149 (0.67%)  1 0/205 (0.00%)  0
CERVICAL SPINAL STENOSIS   0/151 (0.00%)  0 1/149 (0.67%)  1 0/205 (0.00%)  0
CHONDROCALCINOSIS PYROPHOSPHATE   0/151 (0.00%)  0 0/149 (0.00%)  0 1/205 (0.49%)  1
MUSCULOSKELETAL CHEST PAIN   0/151 (0.00%)  0 0/149 (0.00%)  0 1/205 (0.49%)  1
OSTEOARTHRITIS   0/151 (0.00%)  0 0/149 (0.00%)  0 1/205 (0.49%)  1
POLYMYALGIA RHEUMATICA   1/151 (0.66%)  1 0/149 (0.00%)  0 0/205 (0.00%)  0
SPONDYLOLISTHESIS   0/151 (0.00%)  0 0/149 (0.00%)  0 1/205 (0.49%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
CERVIX CARCINOMA STAGE 0   0/151 (0.00%)  0 0/149 (0.00%)  0 1/205 (0.49%)  1
COLORECTAL CANCER   0/151 (0.00%)  0 0/149 (0.00%)  0 1/205 (0.49%)  1
HAEMANGIOMA OF LIVER   0/151 (0.00%)  0 0/149 (0.00%)  0 1/205 (0.49%)  1
OVARIAN LOW MALIGNANT POTENTIAL TUMOUR   0/151 (0.00%)  0 0/149 (0.00%)  0 1/205 (0.49%)  1
PROSTATE CANCER   0/151 (0.00%)  0 0/149 (0.00%)  0 1/205 (0.49%)  1
RENAL CELL CARCINOMA   2/151 (1.32%)  2 0/149 (0.00%)  0 0/205 (0.00%)  0
Nervous system disorders       
CEREBROVASCULAR ACCIDENT   1/151 (0.66%)  1 0/149 (0.00%)  0 0/205 (0.00%)  0
CONVULSION   0/151 (0.00%)  0 1/149 (0.67%)  1 0/205 (0.00%)  0
DIZZINESS   0/151 (0.00%)  0 0/149 (0.00%)  0 1/205 (0.49%)  1
ENCEPHALOPATHY   0/151 (0.00%)  0 0/149 (0.00%)  0 1/205 (0.49%)  1
HEADACHE   0/151 (0.00%)  0 0/149 (0.00%)  0 1/205 (0.49%)  1
HEPATIC ENCEPHALOPATHY   0/151 (0.00%)  0 1/149 (0.67%)  1 1/205 (0.49%)  1
HYPERTENSIVE ENCEPHALOPATHY   0/151 (0.00%)  0 0/149 (0.00%)  0 1/205 (0.49%)  1
LOSS OF CONSCIOUSNESS   1/151 (0.66%)  1 0/149 (0.00%)  0 0/205 (0.00%)  0
METABOLIC ENCEPHALOPATHY   0/151 (0.00%)  0 0/149 (0.00%)  0 3/205 (1.46%)  3
SYNCOPE   1/151 (0.66%)  1 2/149 (1.34%)  2 3/205 (1.46%)  3
TOXICITY TO VARIOUS AGENTS   0/151 (0.00%)  0 1/149 (0.67%)  1 0/205 (0.00%)  0
Psychiatric disorders       
ANXIETY   0/151 (0.00%)  0 1/149 (0.67%)  1 0/205 (0.00%)  0
MENTAL STATUS CHANGES   1/151 (0.66%)  1 0/149 (0.00%)  0 1/205 (0.49%)  1
Renal and urinary disorders       
RENAL CYST HAEMORRHAGE   1/151 (0.66%)  1 0/149 (0.00%)  0 0/205 (0.00%)  0
Reproductive system and breast disorders       
ENDOMETRIAL HYPERPLASIA   0/151 (0.00%)  0 0/149 (0.00%)  0 1/205 (0.49%)  1
Respiratory, thoracic and mediastinal disorders       
ACUTE PULMONARY OEDEMA   1/151 (0.66%)  4 0/149 (0.00%)  0 0/205 (0.00%)  0
ACUTE RESPIRATORY FAILURE   1/151 (0.66%)  1 0/149 (0.00%)  0 0/205 (0.00%)  0
PLEURAL EFFUSION   0/151 (0.00%)  0 0/149 (0.00%)  0 1/205 (0.49%)  2
PNEUMONIA ASPIRATION   1/151 (0.66%)  1 0/149 (0.00%)  0 0/205 (0.00%)  0
PULMONARY CONGESTION   0/151 (0.00%)  0 0/149 (0.00%)  0 1/205 (0.49%)  1
PULMONARY OEDEMA   1/151 (0.66%)  1 0/149 (0.00%)  0 1/205 (0.49%)  1
RESPIRATORY ARREST   0/151 (0.00%)  0 0/149 (0.00%)  0 1/205 (0.49%)  1
RESPIRATORY DISTRESS   0/151 (0.00%)  0 0/149 (0.00%)  0 1/205 (0.49%)  1
RESPIRATORY FAILURE   1/151 (0.66%)  1 0/149 (0.00%)  0 0/205 (0.00%)  0
Skin and subcutaneous tissue disorders       
SKIN ULCER   0/151 (0.00%)  0 0/149 (0.00%)  0 1/205 (0.49%)  1
Surgical and medical procedures       
CARDIOVERSION   0/151 (0.00%)  0 0/149 (0.00%)  0 1/205 (0.49%)  1
Vascular disorders       
ACCELERATED HYPERTENSION   0/151 (0.00%)  0 1/149 (0.67%)  1 0/205 (0.00%)  0
ARTERIOSCLEROSIS   0/151 (0.00%)  0 0/149 (0.00%)  0 1/205 (0.49%)  3
DEEP VEIN THROMBOSIS   2/151 (1.32%)  2 0/149 (0.00%)  0 0/205 (0.00%)  0
HYPERTENSION   1/151 (0.66%)  1 0/149 (0.00%)  0 5/205 (2.44%)  5
HYPERTENSIVE CRISIS   0/151 (0.00%)  0 1/149 (0.67%)  1 4/205 (1.95%)  4
HYPERTENSIVE EMERGENCY   1/151 (0.66%)  1 0/149 (0.00%)  0 0/205 (0.00%)  0
HYPOTENSION   0/151 (0.00%)  0 0/149 (0.00%)  0 1/205 (0.49%)  1
ORTHOSTATIC HYPOTENSION   0/151 (0.00%)  0 1/149 (0.67%)  1 0/205 (0.00%)  0
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE   0/151 (0.00%)  0 1/149 (0.67%)  2 0/205 (0.00%)  0
PERIPHERAL VASCULAR DISORDER   0/151 (0.00%)  0 0/149 (0.00%)  0 1/205 (0.49%)  1
SHOCK   0/151 (0.00%)  0 0/149 (0.00%)  0 1/205 (0.49%)  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 Placebo (Standard Dialysate) Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate Stage 3 Soluble Ferric Pyrophosphate (SFP) in Dialysate
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   100/151 (66.23%)      96/149 (64.43%)      148/205 (72.20%)    
Blood and lymphatic system disorders       
ANAEMIA   7/151 (4.64%)  10 3/149 (2.01%)  4 11/205 (5.37%)  11
Cardiac disorders       
ANGINA PECTORIS   1/151 (0.66%)  1 2/149 (1.34%)  2 7/205 (3.41%)  7
Gastrointestinal disorders       
ABDOMINAL PAIN UPPER   6/151 (3.97%)  6 3/149 (2.01%)  3 7/205 (3.41%)  7
CONSTIPATION   2/151 (1.32%)  2 1/149 (0.67%)  1 11/205 (5.37%)  12
DIARRHOEA   15/151 (9.93%)  17 13/149 (8.72%)  14 30/205 (14.63%)  45
NAUSEA   14/151 (9.27%)  25 11/149 (7.38%)  13 20/205 (9.76%)  31
VOMITING   12/151 (7.95%)  16 5/149 (3.36%)  6 16/205 (7.80%)  18
General disorders       
ASTHENIA   7/151 (4.64%)  7 7/149 (4.70%)  7 9/205 (4.39%)  9
FATIGUE   2/151 (1.32%)  2 7/149 (4.70%)  7 2/205 (0.98%)  2
MALAISE   1/151 (0.66%)  1 2/149 (1.34%)  2 9/205 (4.39%)  10
NON-CARDIAC CHEST PAIN   0/151 (0.00%)  0 1/149 (0.67%)  1 9/205 (4.39%)  9
OEDEMA PERIPHERAL   6/151 (3.97%)  7 8/149 (5.37%)  12 14/205 (6.83%)  27
PAIN   4/151 (2.65%)  4 2/149 (1.34%)  2 10/205 (4.88%)  11
PYREXIA   4/151 (2.65%)  4 7/149 (4.70%)  12 10/205 (4.88%)  11
THROMBOSIS IN DEVICE   5/151 (3.31%)  6 3/149 (2.01%)  3 6/205 (2.93%)  15
Infections and infestations       
NASOPHARYNGITIS   6/151 (3.97%)  9 2/149 (1.34%)  2 9/205 (4.39%)  9
UPPER RESPIRATORY TRACT INFECTION   5/151 (3.31%)  6 4/149 (2.68%)  4 5/205 (2.44%)  6
URINARY TRACT INFECTION   2/151 (1.32%)  2 7/149 (4.70%)  8 3/205 (1.46%)  5
Injury, poisoning and procedural complications       
ARTERIOVENOUS FISTULA SITE COMPLICATION   19/151 (12.58%)  23 17/149 (11.41%)  30 25/205 (12.20%)  58
ARTERIOVENOUS FISTULA SITE HAEMORRHAGE   3/151 (1.99%)  3 4/149 (2.68%)  8 7/205 (3.41%)  14
ARTERIOVENOUS FISTULA THROMBOSIS   3/151 (1.99%)  3 2/149 (1.34%)  2 7/205 (3.41%)  10
HAEMODIALYSIS-INDUCED SYMPTOM   5/151 (3.31%)  9 7/149 (4.70%)  11 39/205 (19.02%)  199
PROCEDURAL DIZZINESS   1/151 (0.66%)  2 1/149 (0.67%)  4 7/205 (3.41%)  9
PROCEDURAL HYPOTENSION   41/151 (27.15%)  216 43/149 (28.86%)  174 68/205 (33.17%)  494
VASCULAR GRAFT COMPLICATION   1/151 (0.66%)  1 4/149 (2.68%)  8 13/205 (6.34%)  25
Metabolism and nutrition disorders       
DECREASED APPETITE   4/151 (2.65%)  5 0/149 (0.00%)  0 8/205 (3.90%)  8
FLUID OVERLOAD   2/151 (1.32%)  5 5/149 (3.36%)  7 8/205 (3.90%)  15
HYPERKALAEMIA   4/151 (2.65%)  4 4/149 (2.68%)  6 7/205 (3.41%)  7
VITAMIN D DEFICIENCY   2/151 (1.32%)  2 0/149 (0.00%)  0 9/205 (4.39%)  34
Musculoskeletal and connective tissue disorders       
ARTHRALGIA   3/151 (1.99%)  3 6/149 (4.03%)  9 15/205 (7.32%)  17
BACK PAIN   4/151 (2.65%)  4 5/149 (3.36%)  6 13/205 (6.34%)  16
MUSCLE SPASMS   11/151 (7.28%)  20 7/149 (4.70%)  15 10/205 (4.88%)  33
MUSCULOSKELETAL PAIN   2/151 (1.32%)  2 2/149 (1.34%)  4 13/205 (6.34%)  16
PAIN IN EXTREMITY   7/151 (4.64%)  7 13/149 (8.72%)  18 13/205 (6.34%)  13
Nervous system disorders       
DIZZINESS   14/151 (9.27%)  16 13/149 (8.72%)  17 26/205 (12.68%)  52
HEADACHE   8/151 (5.30%)  9 14/149 (9.40%)  16 38/205 (18.54%)  53
HYPOAESTHESIA   0/151 (0.00%)  0 5/149 (3.36%)  7 5/205 (2.44%)  5
Psychiatric disorders       
INSOMNIA   3/151 (1.99%)  3 0/149 (0.00%)  0 7/205 (3.41%)  7
Respiratory, thoracic and mediastinal disorders       
COUGH   10/151 (6.62%)  11 11/149 (7.38%)  14 21/205 (10.24%)  27
DYSPNOEA   7/151 (4.64%)  9 6/149 (4.03%)  8 22/205 (10.73%)  34
Vascular disorders       
HYPERTENSION   2/151 (1.32%)  2 3/149 (2.01%)  3 8/205 (3.90%)  9
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
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Name/Title: Senior Director, Clinical Research & Operations
Organization: Rockwell Medical
Phone: 248-960-9009
EMail: rd@rockwellmed.com
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Responsible Party: Rockwell Medical Technologies, Inc.
ClinicalTrials.gov Identifier: NCT01320202     History of Changes
Other Study ID Numbers: RMTI-SFP-4
First Submitted: March 20, 2011
First Posted: March 22, 2011
Results First Submitted: March 20, 2015
Results First Posted: April 28, 2015
Last Update Posted: April 26, 2017