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Trial record 46 of 380 for:    FERRIC CATION

Safety Study of Soluble Ferric Pyrophosphate (SFP) in Dialysate in CKD Patients Receiving Chronic Hemodialysis

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ClinicalTrials.gov Identifier: NCT01503021
Recruitment Status : Completed
First Posted : January 2, 2012
Results First Posted : April 21, 2015
Last Update Posted : October 25, 2016
Sponsor:
Information provided by (Responsible Party):
Rockwell Medical Technologies, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions End Stage Renal Disease
Chronic Kidney Disease
Interventions Drug: SFP
Other: Placebo
Enrollment 718
Recruitment Details  
Pre-assignment Details  
Arm/Group Title SFP/Placebo Placebo/SFP
Hide Arm/Group Description Soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate in liquid bicarbonate concentrate x 2 weeks, then 1 week washout, then standard liquid bicarbonate concentrate without SFP x 2 weeks Standard liquid bicarbonate concentrate without SFP x 2 weeks, then 1 week washout, then soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate in liquid bicarbonate concentrate x 2 weeks.
Period Title: Overall Study
Started 360 358
Dosed 351 352
Completed Treatment 333 333 [1]
Completed 333 332
Not Completed 27 26
Reason Not Completed
Adverse Event             7             6
Death             0             2
Lost to Follow-up             2             0
Physician Decision             3             0
Protocol Violation             1             3
Withdrawal by Subject             9             8
Moved, received transplant, etc.             5             7
[1]
One patient completed the treatment period but discontinued prior to completing the follow-up visit.
Arm/Group Title SFP/Placebo Placebo/SFP Total
Hide Arm/Group Description Soluble ferric pyrophosphate (SFP) 2 µM (110 µg) iron/L of dialysate in liquid bicarbonate concentrate x 2 weeks, then 1 week washout, then standard liquid bicarbonate concentrate without SFP x 2 weeks Standard liquid bicarbonate concentrate without SFP x 2 weeks, then 1 week washout, then soluble ferric pyrophosphate (SFP) 2 µM (110 µg) iron/L of dialysate in liquid bicarbonate concentrate x 2 weeks. Total of all reporting groups
Overall Number of Baseline Participants 351 352 703
Hide Baseline Analysis Population Description
All participants who received at least one dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 351 participants 352 participants 703 participants
59.9  (13.18) 59.5  (13.30) 59.7  (13.23)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 351 participants 352 participants 703 participants
Female
137
  39.0%
141
  40.1%
278
  39.5%
Male
214
  61.0%
211
  59.9%
425
  60.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 351 participants 352 participants 703 participants
Hispanic or Latino
90
  25.6%
106
  30.1%
196
  27.9%
Not Hispanic or Latino
261
  74.4%
246
  69.9%
507
  72.1%
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 351 participants 352 participants 703 participants
American Indian or Alaska Native
5
   1.4%
0
   0.0%
5
   0.7%
Asian
6
   1.7%
8
   2.3%
14
   2.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
154
  43.9%
145
  41.2%
299
  42.5%
White
185
  52.7%
194
  55.1%
379
  53.9%
More than one race
1
   0.3%
5
   1.4%
6
   0.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Incidence of Treatment-emergent Adverse Events
Hide Description Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention.
Time Frame Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug (SFP or placebo, as applicable).
Arm/Group Title Soluble Ferric Pyrophosphate Placebo Open-label Soluble Ferric Pyrophosphate
Hide Arm/Group Description:
Parent Study: Blinded soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
Parent Study: Blinded standard liquid bicarbonate concentrate
Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
Overall Number of Participants Analyzed 693 687 309
Measure Type: Number
Unit of Measure: percentage of participants
31.6 35.1 95.1
2.Primary Outcome
Title Incidence of Treatment-emergent Adverse Events of Intradialytic Hypotension
Hide Description Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. For each adverse event, investigators assessed whether the event met the protocol criteria for intradialytic hypotension. Intradialytic hypotension events were only to have been reported as adverse events if they exceeded the individual subject's baseline pattern of intradialytic hypotension.
Time Frame Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug (SFP or placebo, as applicable).
Arm/Group Title Soluble Ferric Pyrophosphate Placebo Open-label Soluble Ferric Pyrophosphate
Hide Arm/Group Description:
Parent Study: Blinded soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
Parent Study: Blinded standard liquid bicarbonate concentrate
Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
Overall Number of Participants Analyzed 693 687 309
Measure Type: Number
Unit of Measure: percentage of participants
4.3 4.9 12.6
3.Primary Outcome
Title Incidence of Related Suspected Hypersensitivity Reactions
Hide Description Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. For each adverse event, investigators assessed whether the event met protocol criteria for suspected hypersensitivity reactions.
Time Frame Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug (SFP or placebo, as applicable).
Arm/Group Title Soluble Ferric Pyrophosphate Placebo Open-label Soluble Ferric Pyrophosphate
Hide Arm/Group Description:
Parent Study: Blinded soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
Parent Study: Blinded standard liquid bicarbonate concentrate
Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
Overall Number of Participants Analyzed 693 687 309
Measure Type: Number
Unit of Measure: percentage of participants
0 0 0
4.Secondary Outcome
Title Incidence of Composite Cardiovascular Events
Hide Description Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. Adverse event terms meeting criteria for composite cardiovascular events were pre-specified in the statistical analysis plan for the study.
Time Frame Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug (SFP or placebo, as applicable).
Arm/Group Title Soluble Ferric Pyrophosphate Placebo Open-label Soluble Ferric Pyrophosphate
Hide Arm/Group Description:
Parent Study: Blinded soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
Parent Study: Blinded standard liquid bicarbonate concentrate
Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
Overall Number of Participants Analyzed 693 687 309
Measure Type: Number
Unit of Measure: percentage of participants
1.0 0.7 13.6
5.Secondary Outcome
Title Incidence of Hemodialysis Vascular Access Thrombotic Events
Hide Description Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. Adverse event terms meeting criteria for hemodialysis vascular access thrombotic events were pre-specified in the statistical analysis plan for the study.
Time Frame Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug (SFP or placebo, as applicable).
Arm/Group Title Soluble Ferric Pyrophosphate Placebo Open-label Soluble Ferric Pyrophosphate
Hide Arm/Group Description:
Parent Study: Blinded soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
Parent Study: Blinded standard liquid bicarbonate concentrate
Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
Overall Number of Participants Analyzed 693 687 309
Measure Type: Number
Unit of Measure: percentage of participants
0.6 0.6 17.8
6.Secondary Outcome
Title Incidence of Other Thrombotic Events
Hide Description Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. Adverse event terms meeting criteria for other thrombotic events were pre-specified in the statistical analysis plan for the study.
Time Frame Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug (SFP or placebo, as applicable).
Arm/Group Title Soluble Ferric Pyrophosphate Placebo Open-label Soluble Ferric Pyrophosphate
Hide Arm/Group Description:
Parent Study: Blinded soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
Parent Study: Blinded standard liquid bicarbonate concentrate
Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
Overall Number of Participants Analyzed 693 687 309
Measure Type: Number
Unit of Measure: percentage of participants
0 0.1 1.9
7.Secondary Outcome
Title Incidence of Systemic/Serious Infections
Hide Description Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. Adverse events of systemic/serious infections were defined in the statistical analysis plan for the study to include infections for which the subject was administered at least 3 doses of an IV antibiotic, and infections for which the subject was hospitalized.
Time Frame Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug (SFP or placebo, as applicable).
Arm/Group Title Soluble Ferric Pyrophosphate Placebo Open-label Soluble Ferric Pyrophosphate
Hide Arm/Group Description:
Parent Study: Blinded soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
Parent Study: Blinded standard liquid bicarbonate concentrate
Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
Overall Number of Participants Analyzed 693 687 309
Measure Type: Number
Unit of Measure: percentage of participants
0.4 0.9 11.3
8.Secondary Outcome
Title Incidence of Serious Adverse Events
Hide Description Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. For each adverse event, investigators assessed whether the event met seriousness criteria.
Time Frame Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug (SFP or placebo, as applicable).
Arm/Group Title Soluble Ferric Pyrophosphate Placebo Open-label Soluble Ferric Pyrophosphate
Hide Arm/Group Description:
Parent Study: Blinded soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
Parent Study: Blinded standard liquid bicarbonate concentrate
Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
Overall Number of Participants Analyzed 693 687 309
Measure Type: Number
Unit of Measure: percentage of participants
4.3 5.1 46.6
9.Other Pre-specified Outcome
Title Serum Iron Change From Pre-dialysis to Post-dialysis at Week 2
Hide Description Serum iron was assessed from samples obtained pre-dialysis and post-dialysis at a single hemodialysis during study week 2. Because of the crossover nature of the study, the week 2 values reflect effects of SFP in the SFP/Placebo arm and effects of Placebo in the Placebo/SFP arm.
Time Frame Pre-dialysis and post-dialysis during study week 2 of the Parent (Crossover) Study
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug (SFP or placebo, as applicable).
Arm/Group Title SFP/Placebo Placebo/SFP
Hide Arm/Group Description:

Parent Study: Blinded soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate, then 1 week washout, then blinded standard liquid bicarbonate concentrate without SFP x 2 weeks

SFP: Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate

Placebo: Dialysis with standard liquid bicarbonate concentrate without iron

Parent Study: Blinded standard liquid bicarbonate concentrate without SFP x 2 weeks, then 1 week washout, then soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate x 2 weeks.

SFP: Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate

Placebo: Dialysis with standard liquid bicarbonate concentrate without iron

Overall Number of Participants Analyzed 307 311
Mean (Standard Deviation)
Unit of Measure: micromoles per liter
Pre-dialysis 13.66  (5.435) 13.65  (5.299)
Post-dialysis 38.60  (10.151) 14.97  (7.753)
Change from pre-dialysis to post-dialysis 24.91  (9.243) 1.36  (5.447)
10.Other Pre-specified Outcome
Title Serum Iron Change From Pre-dialysis to Post-dialysis at Week 5
Hide Description Serum iron was assessed from samples obtained pre-dialysis and post-dialysis at a single hemodialysis during study week 5. Because of the crossover nature of the study, the week 5 values reflect effects of Placebo in the SFP/Placebo arm and effects of SFP in the Placebo/SFP arm.
Time Frame Pre-dialysis and post-dialysis during study week 5 of the Parent (Crossover) Study
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug (SFP or placebo, as applicable).
Arm/Group Title SFP/Placebo Placebo/SFP
Hide Arm/Group Description:

Parent Study: Blinded soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate, then 1 week washout, then blinded standard liquid bicarbonate concentrate without SFP x 2 weeks

SFP: Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate

Placebo: Dialysis with standard liquid bicarbonate concentrate without iron

Parent Study: Blinded standard liquid bicarbonate concentrate without SFP x 2 weeks, then 1 week washout, then soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate x 2 weeks.

SFP: Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate

Placebo: Dialysis with standard liquid bicarbonate concentrate without iron

Overall Number of Participants Analyzed 299 303
Mean (Standard Deviation)
Unit of Measure: micromoles per liter
Pre-dialysis 12.97  (4.731) 13.02  (4.856)
Post-dialysis 13.98  (7.884) 37.79  (11.183)
Change from pre-dialysis to post-dialysis 1.12  (6.834) 24.82  (9.827)
11.Other Pre-specified Outcome
Title Unsaturated Iron-binding Capacity Change From Pre-dialysis to Post-dialysis at Week 2
Hide Description Unsaturated iron-binding capacity was assessed from samples obtained pre-dialysis and post-dialysis at a single hemodialysis during study week 2. Because of the crossover nature of the study, the week 2 values reflect effects of SFP in the SFP/Placebo arm and effects of Placebo in the Placebo/SFP arm.
Time Frame Pre-dialysis and post-dialysis during study week 2 of the Parent (Crossover) Study
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug (SFP or placebo, as applicable).
Arm/Group Title SFP/Placebo Placebo/SFP
Hide Arm/Group Description:

Parent Study: Blinded soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate, then 1 week washout, then blinded standard liquid bicarbonate concentrate without SFP x 2 weeks

SFP: Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate

Placebo: Dialysis with standard liquid bicarbonate concentrate without iron

Parent Study: Blinded standard liquid bicarbonate concentrate without SFP x 2 weeks, then 1 week washout, then soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate x 2 weeks.

SFP: Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate

Placebo: Dialysis with standard liquid bicarbonate concentrate without iron

Overall Number of Participants Analyzed 351 352
Mean (Standard Deviation)
Unit of Measure: micromoles per liter
Pre-dialysis 27.95  (6.310) 28.05  (7.442)
Post-dialysis 11.44  (6.899) 30.49  (8.909)
Change from pre-dialysis to post-dialysis -16.47  (7.040) 2.49  (4.910)
12.Other Pre-specified Outcome
Title Unsaturated Iron-binding Capacity Change From Pre-dialysis to Post-dialysis at Week 5
Hide Description Unsaturated iron-binding capacity was assessed from samples obtained pre-dialysis and post-dialysis at a single hemodialysis during study week 5. Because of the crossover nature of the study, the week 5 values reflect effects of Placebo in the SFP/Placebo arm and effects of SFP in the Placebo/SFP arm.
Time Frame Pre-dialysis and post-dialysis during study week 5 of the Parent (Crossover) Study
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug (SFP or placebo, as applicable).
Arm/Group Title SFP/Placebo Placebo/SFP
Hide Arm/Group Description:

Parent Study: Blinded soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate, then 1 week washout, then blinded standard liquid bicarbonate concentrate without SFP x 2 weeks

SFP: Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate

Placebo: Dialysis with standard liquid bicarbonate concentrate without iron

Parent Study: Blinded standard liquid bicarbonate concentrate without SFP x 2 weeks, then 1 week washout, then soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate x 2 weeks.

SFP: Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate

Placebo: Dialysis with standard liquid bicarbonate concentrate without iron

Overall Number of Participants Analyzed 351 352
Mean (Standard Deviation)
Unit of Measure: micromoles per liter
Pre-dialysis 28.80  (6.745) 29.05  (7.311)
Post-dialysis 30.95  (8.488) 12.41  (8.463)
Change from pre-dialysis to post-dialysis 2.05  (5.333) -16.68  (7.452)
13.Other Pre-specified Outcome
Title Transferrin Saturation Change From Pre-dialysis to Post-dialysis at Week 2
Hide Description Transferrin saturation (based on TIBC derived from transferrin levels) was assessed from samples obtained pre-dialysis and post-dialysis at a single hemodialysis during study week 2. Because of the crossover nature of the study, the week 2 values reflect effects of SFP in the SFP/Placebo arm and effects of Placebo in the Placebo/SFP arm.
Time Frame Pre-dialysis and post-dialysis during study week 2 of the Parent (Crossover) Study
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug (SFP or placebo, as applicable).
Arm/Group Title SFP/Placebo Placebo/SFP
Hide Arm/Group Description:

Parent Study: Blinded soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate, then 1 week washout, then blinded standard liquid bicarbonate concentrate without SFP x 2 weeks

SFP: Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate

Placebo: Dialysis with standard liquid bicarbonate concentrate without iron

Parent Study: Blinded standard liquid bicarbonate concentrate without SFP x 2 weeks, then 1 week washout, then soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate x 2 weeks.

SFP: Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate

Placebo: Dialysis with standard liquid bicarbonate concentrate without iron

Overall Number of Participants Analyzed 351 352
Mean (Standard Deviation)
Unit of Measure: percent transferrin saturation
Pre-dialysis 30.31  (11.357) 30.46  (11.849)
Post-dialysis 80.85  (17.646) 30.23  (14.397)
Change from pre-dialysis to post-dialysis 50.44  (17.442) -0.25  (10.348)
14.Other Pre-specified Outcome
Title Transferrin Saturation Change From Pre-dialysis to Post-dialysis at Week 5
Hide Description Transferrin saturation (based on TIBC derived from transferrin levels) was assessed from samples obtained pre-dialysis and post-dialysis at a single hemodialysis during study week 5. Because of the crossover nature of the study, the week 5 values reflect effects of Placebo in the SFP/Placebo arm and effects of SFP in the Placebo/SFP arm.
Time Frame Pre-dialysis and post-dialysis during study week 5 of the Parent (Crossover) Study
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug (SFP or placebo, as applicable).
Arm/Group Title SFP/Placebo Placebo/SFP
Hide Arm/Group Description:

Parent Study: Blinded soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate, then 1 week washout, then blinded standard liquid bicarbonate concentrate without SFP x 2 weeks

SFP: Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate

Placebo: Dialysis with standard liquid bicarbonate concentrate without iron

Parent Study: Blinded standard liquid bicarbonate concentrate without SFP x 2 weeks, then 1 week washout, then soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate x 2 weeks.

SFP: Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate

Placebo: Dialysis with standard liquid bicarbonate concentrate without iron

Overall Number of Participants Analyzed 351 352
Mean (Standard Deviation)
Unit of Measure: percent transferrin saturation
Pre-dialysis 26.75  (10.302) 28.88  (10.585)
Post-dialysis 28.73  (15.818) 79.18  (20.008)
Change from pre-dialysis to post-dialysis 0.10  (13.792) 50.42  (18.163)
15.Other Pre-specified Outcome
Title Ferritin
Hide Description The baseline and end of treatment predialysis ferritin levels were evaluated for the 52-week extension study to determine whether soluble ferric pyrophosphate increases iron stores.
Time Frame Baseline, up to 53 weeks for Extension Study
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug (SFP or placebo, as applicable).
Arm/Group Title Open-label Soluble Ferric Pyrophosphate
Hide Arm/Group Description:
Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
Overall Number of Participants Analyzed 309
Mean (Standard Deviation)
Unit of Measure: micrograms per liter
Baseline 653.0  (288.70)
End of Treatment 520.3  (341.84)
Change from Baseline -132.0  (311.15)
16.Other Pre-specified Outcome
Title Serum Iron
Hide Description The baseline and end of treatment predialysis serum iron levels were evaluated for the 52-week extension study to determine the effect of soluble ferric pyrophosphate on serum iron.
Time Frame Baseline, up to 53 weeks for Extension Study
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug (SFP or placebo, as applicable).
Arm/Group Title Open-label Soluble Ferric Pyrophosphate
Hide Arm/Group Description:
Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
Overall Number of Participants Analyzed 309
Mean (Standard Deviation)
Unit of Measure: micromoles per liter
Baseline 12.650  (4.6488)
End of Treatment 11.815  (5.3443)
Change from Baseline -0.772  (5.2686)
17.Other Pre-specified Outcome
Title Transferrin Saturation
Hide Description The baseline and end of treatment predialysis transferrin saturation were evaluated for the 52-week extension study to confirm clearance of iron derived from soluble ferric pyrophosphate.
Time Frame Baseline, up to 53 weeks for Extension Study
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug (SFP or placebo, as applicable).
Arm/Group Title Open-label Soluble Ferric Pyrophosphate
Hide Arm/Group Description:
Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
Overall Number of Participants Analyzed 309
Mean (Standard Deviation)
Unit of Measure: percent transferrin saturation
Baseline 30.050  (10.0504)
End of Treatment 28.114  (11.5075)
Change from Baseline -1.835  (11.7221)
18.Other Pre-specified Outcome
Title Incidence of Patients Meeting Hy's Law Criteria
Hide Description The peak alanine aminotransferase and the peak total bilirubin levels were evaluated per patient. Laboratory values for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. Patients with alanine aminotransferase more than three times the upper limit of normal and also total bilirubin more than two times the upper limit of normal are counted.
Time Frame Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug (SFP or placebo, as applicable).
Arm/Group Title Soluble Ferric Pyrophosphate Placebo Open-label Soluble Ferric Pyrophosphate
Hide Arm/Group Description:
Parent Study: Blinded soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
Parent Study: Blinded standard liquid bicarbonate concentrate
Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
Overall Number of Participants Analyzed 693 687 309
Measure Type: Number
Unit of Measure: participants
0 0 0
Time Frame Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study
Adverse Event Reporting Description Adverse events for a given intervention are counted from the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. Information regarding adverse events was elicited from participants using non-leading questions at each study visit, which generally occurred 3 times per week during the study.
 
Arm/Group Title Soluble Ferric Pyrophosphate Placebo Open-label Soluble Ferric Pyrophosphate
Hide Arm/Group Description Parent Study: Blinded soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter. Parent Study: Blinded standard liquid bicarbonate concentrate Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
All-Cause Mortality
Soluble Ferric Pyrophosphate Placebo Open-label Soluble Ferric Pyrophosphate
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Soluble Ferric Pyrophosphate Placebo Open-label Soluble Ferric Pyrophosphate
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   30/693 (4.33%)   35/687 (5.09%)   144/309 (46.60%) 
Blood and lymphatic system disorders       
Anaemia * 1  0/693 (0.00%)  1/687 (0.15%)  5/309 (1.62%) 
Coagulopathy * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Haemorrhagic anaemia * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Cardiac disorders       
Acute myocardial infarction * 1  4/693 (0.58%)  1/687 (0.15%)  5/309 (1.62%) 
Angina pectoris * 1  0/693 (0.00%)  1/687 (0.15%)  5/309 (1.62%) 
Atrial fibrillation * 1  0/693 (0.00%)  1/687 (0.15%)  4/309 (1.29%) 
Cardiac arrest * 1  0/693 (0.00%)  1/687 (0.15%)  4/309 (1.29%) 
Cardiac failure congestive * 1  1/693 (0.14%)  2/687 (0.29%)  6/309 (1.94%) 
Coronary artery disease * 1  0/693 (0.00%)  2/687 (0.29%)  5/309 (1.62%) 
Myocardial infarction * 1  1/693 (0.14%)  3/687 (0.44%)  1/309 (0.32%) 
Pericardial effusion * 1  1/693 (0.14%)  0/687 (0.00%)  2/309 (0.65%) 
Sinus tachycardia * 1  0/693 (0.00%)  1/687 (0.15%)  0/309 (0.00%) 
Angina unstable * 1  0/693 (0.00%)  0/687 (0.00%)  3/309 (0.97%) 
Arteriosclerosis coronary artery * 1  0/693 (0.00%)  0/687 (0.00%)  2/309 (0.65%) 
Ischaemic cardiomyopathy * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Sick sinus syndrome * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Tachycardia * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Ventricular tachycardia * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Congenital, familial and genetic disorders       
Gastrointestinal arteriovenous malformation * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Eye disorders       
Retinal artery embolism * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Gastrointestinal disorders       
Anal fistula * 1  0/693 (0.00%)  1/687 (0.15%)  0/309 (0.00%) 
Duodenal ulcer haemorrhage * 1  1/693 (0.14%)  0/687 (0.00%)  0/309 (0.00%) 
Dysphagia * 1  1/693 (0.14%)  0/687 (0.00%)  0/309 (0.00%) 
Enterovesical fistula * 1  0/693 (0.00%)  1/687 (0.15%)  0/309 (0.00%) 
Impaired gastric emptying * 1  1/693 (0.14%)  1/687 (0.15%)  0/309 (0.00%) 
Lower gastrointestinal haemorrhage * 1  0/693 (0.00%)  1/687 (0.15%)  1/309 (0.32%) 
Pancreatitis * 1  1/693 (0.14%)  0/687 (0.00%)  0/309 (0.00%) 
Upper gastrointestinal haemorrhage * 1  0/693 (0.00%)  1/687 (0.15%)  2/309 (0.65%) 
Gastrointestinal haemorrhage * 1  0/693 (0.00%)  0/687 (0.00%)  8/309 (2.59%) 
Abdominal pain * 1  0/693 (0.00%)  0/687 (0.00%)  2/309 (0.65%) 
Small intestinal obstruction * 1  0/693 (0.00%)  0/687 (0.00%)  2/309 (0.65%) 
Abdominal pain lower * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Colitis * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Duodenitis * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Gastric ulcer * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Intestinal perforation * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Oesophagitis * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Rectal haemorrhage * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
General disorders       
Gait disturbance * 1  1/693 (0.14%)  0/687 (0.00%)  0/309 (0.00%) 
Systemic inflammatory response syndrome * 1  0/693 (0.00%)  1/687 (0.15%)  0/309 (0.00%) 
Non-cardiac chest pain * 1  0/693 (0.00%)  0/687 (0.00%)  4/309 (1.29%) 
Asthenia * 1  0/693 (0.00%)  0/687 (0.00%)  2/309 (0.65%) 
Chest pain * 1  0/693 (0.00%)  0/687 (0.00%)  2/309 (0.65%) 
Medical device complication * 1  0/693 (0.00%)  0/687 (0.00%)  2/309 (0.65%) 
Pyrexia * 1  0/693 (0.00%)  0/687 (0.00%)  2/309 (0.65%) 
Adverse drug reaction * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Device pacing issue * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Malaise * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Sudden death * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Hepatobiliary disorders       
Cholecystitis acute * 1  1/693 (0.14%)  0/687 (0.00%)  0/309 (0.00%) 
Cholelithiasis * 1  0/693 (0.00%)  0/687 (0.00%)  3/309 (0.97%) 
Biliary dyskinesia * 1  0/693 (0.00%)  0/687 (0.00%)  2/309 (0.65%) 
Cholecystitis * 1  0/693 (0.00%)  0/687 (0.00%)  2/309 (0.65%) 
Bile duct obstruction * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Biliary colic * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Hepatic necrosis * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Immune system disorders       
Anaphylactic reaction * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Drug hypersensitivity * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Infections and infestations       
Bacteraemia * 1  0/693 (0.00%)  1/687 (0.15%)  4/309 (1.29%) 
Bronchitis * 1  0/693 (0.00%)  2/687 (0.29%)  6/309 (1.94%) 
Cholecystitis infective * 1  0/693 (0.00%)  1/687 (0.15%)  0/309 (0.00%) 
Device related infection * 1  0/693 (0.00%)  1/687 (0.15%)  1/309 (0.32%) 
Gastroenteritis * 1  1/693 (0.14%)  1/687 (0.15%)  2/309 (0.65%) 
Lobar pneumonia * 1  0/693 (0.00%)  1/687 (0.15%)  0/309 (0.00%) 
Pneumonia * 1  0/693 (0.00%)  5/687 (0.73%)  7/309 (2.27%) 
Pneumonia primary atypical * 1  1/693 (0.14%)  0/687 (0.00%)  0/309 (0.00%) 
Streptococcal sepsis * 1  1/693 (0.14%)  0/687 (0.00%)  0/309 (0.00%) 
Viral infection * 1  1/693 (0.14%)  0/687 (0.00%)  1/309 (0.32%) 
Sepsis * 1  0/693 (0.00%)  0/687 (0.00%)  6/309 (1.94%) 
Cellulitis * 1  0/693 (0.00%)  0/687 (0.00%)  5/309 (1.62%) 
Gangrene * 1  0/693 (0.00%)  0/687 (0.00%)  4/309 (1.29%) 
Septic shock * 1  0/693 (0.00%)  0/687 (0.00%)  4/309 (1.29%) 
Diabetic foot infection * 1  0/693 (0.00%)  0/687 (0.00%)  3/309 (0.97%) 
Urinary tract infection * 1  0/693 (0.00%)  0/687 (0.00%)  3/309 (0.97%) 
Arteriovenous fistula site infection * 1  0/693 (0.00%)  0/687 (0.00%)  2/309 (0.65%) 
Staphylococcal bacteraemia * 1  0/693 (0.00%)  0/687 (0.00%)  2/309 (0.65%) 
Abscess limb * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Arteriovenous graft site infection * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Chest wall abscess * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Clostridium difficile colitis * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Escherichia urinary tract infection * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Gastroenteritis viral * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Nasal abscess * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Necrotising fasciitis * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Osteomyelitis * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Pharyngitis * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Pneumonia influenzal * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Streptococcal bacteraemia * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Wound sepsis * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Injury, poisoning and procedural complications       
Arteriovenous fistula site haemorrhage * 1  1/693 (0.14%)  0/687 (0.00%)  1/309 (0.32%) 
Arteriovenous fistula thrombosis * 1  1/693 (0.14%)  1/687 (0.15%)  5/309 (1.62%) 
Hip fracture * 1  1/693 (0.14%)  2/687 (0.29%)  2/309 (0.65%) 
Humerus fracture * 1  0/693 (0.00%)  1/687 (0.15%)  1/309 (0.32%) 
Postoperative ileus * 1  0/693 (0.00%)  1/687 (0.15%)  0/309 (0.00%) 
Procedural hypotension  1  0/693 (0.00%)  1/687 (0.15%)  0/309 (0.00%) 
Subdural haematoma * 1  0/693 (0.00%)  1/687 (0.15%)  1/309 (0.32%) 
Vascular graft thrombosis * 1  1/693 (0.14%)  1/687 (0.15%)  7/309 (2.27%) 
Areriovenous fistula aneurysm * 1  0/693 (0.00%)  0/687 (0.00%)  2/309 (0.65%) 
Arteriovenous fistula site complication * 1  0/693 (0.00%)  0/687 (0.00%)  2/309 (0.65%) 
Ankle fracture * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Arteriovenous graft site haemorrhage * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Burns third degree * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Contusion * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Fall * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Muscle strain * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Post procedural myocardial infarction * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Toxicity to various agents * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Vascular graft complication * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Wrist fracture * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Investigations       
International normalised ratio increased * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Metabolism and nutrition disorders       
Hyperkalaemia * 1  2/693 (0.29%)  1/687 (0.15%)  7/309 (2.27%) 
Hypoglycaemia * 1  2/693 (0.29%)  0/687 (0.00%)  3/309 (0.97%) 
Fluid overload * 1  0/693 (0.00%)  0/687 (0.00%)  9/309 (2.91%) 
Diabetic foot * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Failure to thrive * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Hypocalcaemia * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Hypokalaemia * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Musculoskeletal and connective tissue disorders       
Arthralgia * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Bone cyst * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Muscular weakness * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Osteoarthritis * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Plantar fasciitis * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Rhabdomyolysis * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Systemic lupus erythematosus * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Bladder cancer * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Breast cancer in situ * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Metastatic renal cell carcinoma * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Nervous system disorders       
Cerebrovascular accident * 1  1/693 (0.14%)  0/687 (0.00%)  1/309 (0.32%) 
Convulsion * 1  0/693 (0.00%)  1/687 (0.15%)  0/309 (0.00%) 
Metabolic encephalopathy * 1  0/693 (0.00%)  1/687 (0.15%)  3/309 (0.97%) 
Syncope * 1  2/693 (0.29%)  1/687 (0.15%)  5/309 (1.62%) 
Transient ischaemic attack * 1  1/693 (0.14%)  0/687 (0.00%)  3/309 (0.97%) 
Hepatic encephalopathy * 1  0/693 (0.00%)  0/687 (0.00%)  3/309 (0.97%) 
Uraemic encephalopathy * 1  0/693 (0.00%)  0/687 (0.00%)  2/309 (0.65%) 
Haemorrhage intracranial * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Subarachnoid haemorrhage * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Vascular dementia * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Psychiatric disorders       
Bipolar disorder * 1  1/693 (0.14%)  0/687 (0.00%)  0/309 (0.00%) 
Mental status changes * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Renal and urinary disorders       
Azotaemia * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Nephrolithiasis * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Respiratory, thoracic and mediastinal disorders       
Acute pulmonary oedema * 1  1/693 (0.14%)  0/687 (0.00%)  0/309 (0.00%) 
Acute respiratory failure * 1  0/693 (0.00%)  2/687 (0.29%)  3/309 (0.97%) 
Chronic obstructive pulmonary disease * 1  1/693 (0.14%)  0/687 (0.00%)  3/309 (0.97%) 
Dyspnoea * 1  1/693 (0.14%)  0/687 (0.00%)  2/309 (0.65%) 
Epistaxis * 1  0/693 (0.00%)  1/687 (0.15%)  0/309 (0.00%) 
Pleural effusion * 1  0/693 (0.00%)  1/687 (0.15%)  3/309 (0.97%) 
Pulmonary oedema * 1  3/693 (0.43%)  1/687 (0.15%)  4/309 (1.29%) 
Respiratory arrest * 1  0/693 (0.00%)  1/687 (0.15%)  1/309 (0.32%) 
Pulmonary oedema * 1  0/693 (0.00%)  0/687 (0.00%)  4/309 (1.29%) 
Respiratory failure * 1  0/693 (0.00%)  0/687 (0.00%)  2/309 (0.65%) 
Asthma * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Mediastinal haemorrhage * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Pleurisy * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Skin and subcutaneous tissue disorders       
Rash macular * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Skin ulcer * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Vascular disorders       
Deep vein thrombosis * 1  0/693 (0.00%)  1/687 (0.15%)  1/309 (0.32%) 
Hypertensive crisis * 1  1/693 (0.14%)  0/687 (0.00%)  2/309 (0.65%) 
Peripheral vascular disorder * 1  0/693 (0.00%)  1/687 (0.15%)  4/309 (1.29%) 
Peripheral arterial occlusive disease * 1  0/693 (0.00%)  0/687 (0.00%)  2/309 (0.65%) 
Haematoma * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Hypertension * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Hypotension * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Peripheral embolism * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Peripheral ischaemia * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Steal syndrome * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Subclavian vein thrombosis * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Superior vena cava syndrome * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Venous occlusion * 1  0/693 (0.00%)  0/687 (0.00%)  1/309 (0.32%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Soluble Ferric Pyrophosphate Placebo Open-label Soluble Ferric Pyrophosphate
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   123/693 (17.75%)   131/687 (19.07%)   253/309 (81.88%) 
Blood and lymphatic system disorders       
Anaemia * 1  8/693 (1.15%)  6/687 (0.87%)  20/309 (6.47%) 
Gastrointestinal disorders       
Diarrhoea * 1  9/693 (1.30%)  15/687 (2.18%)  53/309 (17.15%) 
Nausea * 1  12/693 (1.73%)  12/687 (1.75%)  61/309 (19.74%) 
Vomiting * 1  8/693 (1.15%)  8/687 (1.16%)  37/309 (11.97%) 
Abdominal pain * 1  3/693 (0.43%)  0/687 (0.00%)  24/309 (7.77%) 
General disorders       
Oedema peripheral * 1  5/693 (0.72%)  8/687 (1.16%)  36/309 (11.65%) 
Pyrexia * 1  1/693 (0.14%)  1/687 (0.15%)  27/309 (8.74%) 
Infections and infestations       
Upper respiratory tract infection * 1  4/693 (0.58%)  9/687 (1.31%)  26/309 (8.41%) 
Nasopharyngitis * 1  4/693 (0.58%)  1/687 (0.15%)  16/309 (5.18%) 
Urinary tract infection * 1  2/693 (0.29%)  3/687 (0.44%)  21/309 (6.80%) 
Injury, poisoning and procedural complications       
Arteriovenous fistula site complication * 1  11/693 (1.59%)  9/687 (1.31%)  56/309 (18.12%) 
Procedural hypotension * 1  32/693 (4.62%)  32/687 (4.66%)  39/309 (12.62%) 
Arteriovenous fistula thrombosis * 1  3/693 (0.43%)  3/687 (0.44%)  24/309 (7.77%) 
Haemodialysis-induced symptom * 1  4/693 (0.58%)  3/687 (0.44%)  49/309 (15.86%) 
Vascular graft complication * 1  2/693 (0.29%)  2/687 (0.29%)  27/309 (8.74%) 
Vascular graft thrombosis * 1  2/693 (0.29%)  3/687 (0.44%)  23/309 (7.44%) 
Metabolism and nutrition disorders       
Fluid overload * 1  5/693 (0.72%)  1/687 (0.15%)  18/309 (5.83%) 
Hyperkalaemia * 1  1/693 (0.14%)  4/687 (0.58%)  20/309 (6.47%) 
Musculoskeletal and connective tissue disorders       
Muscle spasms * 1  17/693 (2.45%)  15/687 (2.18%)  20/309 (6.47%) 
Back pain * 1  3/693 (0.43%)  1/687 (0.15%)  32/309 (10.36%) 
Pain in extremity * 1  2/693 (0.29%)  4/687 (0.58%)  32/309 (10.36%) 
Nervous system disorders       
Dizziness * 1  5/693 (0.72%)  7/687 (1.02%)  37/309 (11.97%) 
Respiratory, thoracic and mediastinal disorders       
Cough * 1  4/693 (0.58%)  10/687 (1.46%)  25/309 (8.09%) 
Dyspnoea * 1  8/693 (1.15%)  2/687 (0.29%)  27/309 (8.74%) 
Vascular disorders       
Hypertension * 1  7/693 (1.01%)  5/687 (0.73%)  26/309 (8.41%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.1
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
Organization: Rockwell Medical, Inc
Phone: 248-960-9009
EMail: rd@rockwellmed.com
Layout table for additonal information
Responsible Party: Rockwell Medical Technologies, Inc.
ClinicalTrials.gov Identifier: NCT01503021     History of Changes
Other Study ID Numbers: RMTI-SFP-6
First Submitted: December 29, 2011
First Posted: January 2, 2012
Results First Submitted: April 3, 2015
Results First Posted: April 21, 2015
Last Update Posted: October 25, 2016