CompletedNCT01503021Updated Oct 25, 2016Results posted

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

A Phase 3 interventional study of SFP and Placebo in End Stage Renal Disease and Chronic Kidney Disease, sponsored by Rockwell Medical Technologies, Inc.. Completed at 31 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-10-25.

Sponsored by Rockwell Medical Technologies, Inc. · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 718
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

The purpose of the parent study is to assess the short-term safety and tolerability of soluble ferric pyrophosphate (SFP) in dialysate administered to a large number of representative adult chronic kidney disease patients on hemodialysis (CKD-HD).

The purpose of the extension study is to assess the long-term safety and tolerability of SFP.

Read the detailed description

Parent Study: randomized, double-blinded, crossover, up to 6 weeks, 700 patients. Patients were randomized to receive SFP 2 µmoles (110 µg) iron/L of dialysate in liquid bicarbonate concentrate or placebo (standard liquid bicarbonate concentrate) x 2 weeks, then a 1 week washout, then crossed over to the alternate treatment x 2 weeks.

Extension Study: open-label, single active arm, uncontrolled study, up to 53 weeks, 300 patients. Following completion of the RMTI-SFP-6 parent study, patients could enter the extension study, where they received SFP 2 µmoles (110 µg) iron/L of dialysate in liquid bicarbonate concentrate for up to 52 weeks.

Conditions studied

End Stage Renal Disease
Chronic Kidney Disease

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Keywords

Soluble ferric pyrophosphate
Chronic kidney disease
Chronic hemodialysis
Ferric pyrophosphate citrate

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's enrollment of 718 is above the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

Rockwell Medical Technologies, Inc. is the lead sponsor of 18 studies on the registry; none are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 5 (83%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

Parent Study, Double Blinded, Crossover:

Key Inclusion Criteria:

Adult ≥ 18 years of age.
Has chronic kidney disease (CKD) receiving maintenance hemodialysis (HD) (CKD-HD subjects) and regularly undergoing 2 or more dialysis sessions per week.
Stable pre-dialysis Hgb ≥ 9.0 to ≤ 12.5 g/dL.
Stable pre-dialysis TSAT ≥ 15% to ≤ 45%.
Stable pre-dialysis ferritin ≥ 100 to ≤ 1200 µg/L (1200 ng/mL).

Key Exclusion Criteria:

Any previous exposure to SFP.
Therapy with intravenous, intramuscular or oral iron at any time between the first/screening visit and the randomization visit, or anticipated requirement for iron supplementation during the study period.
Non-tunneled vascular catheter for dialysis.
Scheduled for kidney transplant within the next 8 weeks.
Active infection requiring systemic antimicrobial or antifungal therapy within 2 weeks prior to screening, or during screening period prior to randomization.
Hospitalization within 1 month prior to screening (except for vascular access surgery).

Extension Study, Open Label, Single Active Arm:

Key Inclusion Criteria:

Participated in Parent Study RMTI-SFP-6 and completed the follow-up/early term visit.
Hemoglobin ≤12.0 g/dL at screening.
TSAT ≤45% at screening. (Excursion of TSAT by ≤10% outside this range permitted only if all other inclusion/exclusion criteria are met).
Serum ferritin ≤1000 µg/L at screening. (Excursion of ferritin by ≤10% outside this range permitted only if all other inclusion/exclusion criteria are met).

Key Exclusion Criteria:

Had a serious adverse event attributable (i.e., probably, possibly, or definitely related) to study drug or had an adverse event attributable to study drug that necessitated premature withdrawal from the double-blind, placebo-controlled crossover phase of the parent study RMTI-SFP-6.
Non-tunneled vascular catheter for dialysis.
Scheduled for kidney transplant within 12 weeks after entry into extension phase.
Active infection requiring systemic antimicrobial or antifungal therapy within 2 weeks prior to dosing.
Pregnancy or intention to become pregnant during the study.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 718 participants (actual)

Study arms

Other
SFP/Placebo
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
Drug: SFP · Other: Placebo
Other
Placebo/SFP
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.
Drug: SFP · Other: Placebo

Interventions

DrugSFP
Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate
Also known as: Soluble ferric pyrophosphate
OtherPlacebo
Dialysis with standard liquid bicarbonate concentrate without iron
Also known as: Standard liquid bicarbonate concentrate

What researchers measure

Primary outcomes

Incidence of Treatment-emergent Adverse Events
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
Incidence of Treatment-emergent Adverse Events of Intradialytic Hypotension
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
Incidence of Related Suspected Hypersensitivity Reactions
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

Secondary outcomes

Incidence of Composite Cardiovascular Events
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
Incidence of Hemodialysis Vascular Access Thrombotic Events
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
Incidence of Other Thrombotic Events
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
Incidence of Systemic/Serious Infections
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
Incidence of Serious Adverse Events
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

Other outcomes

Serum Iron Change From Pre-dialysis to Post-dialysis at Week 2
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
Serum Iron Change From Pre-dialysis to Post-dialysis at Week 5
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
Unsaturated Iron-binding Capacity Change From Pre-dialysis to Post-dialysis at Week 2
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
Unsaturated Iron-binding Capacity Change From Pre-dialysis to Post-dialysis at Week 5
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
Transferrin Saturation Change From Pre-dialysis to Post-dialysis at Week 2
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
Transferrin Saturation Change From Pre-dialysis to Post-dialysis at Week 5
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
Ferritin
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
Serum Iron
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
Transferrin Saturation
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
Incidence of Patients Meeting Hy's Law Criteria
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

Results

Posted Apr 21, 2015

Participant flow

Participant flow — Overall Study
Milestone	SFP/Placebo	Placebo/SFP
Started	360	358
Dosed	351	352
Completed treatment	333	333
Completed	333	332
Not completed	27	26
Withdrew: Adverse event	7	6
Withdrew: Death	0	2
Withdrew: Lost to follow-up	2	0
Withdrew: Physician decision	3	0
Withdrew: Protocol violation	1	3
Withdrew: Withdrawal by subject	9	8
Withdrew: Moved, received transplant, etc.	5	7

Outcome measures

PrimaryIncidence of Treatment-emergent Adverse Events

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
Reported as:: Number · percentage of participants

Incidence of Treatment-emergent Adverse Events
percentage of participants	Soluble Ferric Pyrophosphate	Placebo	Open-label Soluble Ferric Pyrophosphate
Incidence of Treatment-emergent Adverse Events	31.6	35.1	95.1

PrimaryIncidence of Treatment-emergent Adverse Events of Intradialytic Hypotension

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
Reported as:: Number · percentage of participants

Incidence of Treatment-emergent Adverse Events of Intradialytic Hypotension
percentage of participants	Soluble Ferric Pyrophosphate	Placebo	Open-label Soluble Ferric Pyrophosphate
Incidence of Treatment-emergent Adverse Events of Intradialytic Hypotension	4.3	4.9	12.6

PrimaryIncidence of Related Suspected Hypersensitivity Reactions

Time frame:: Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study
Reported as:: Number · percentage of participants

Incidence of Related Suspected Hypersensitivity Reactions
percentage of participants	Soluble Ferric Pyrophosphate	Placebo	Open-label Soluble Ferric Pyrophosphate
Incidence of Related Suspected Hypersensitivity Reactions	0	0	0

SecondaryIncidence of Composite Cardiovascular Events

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
Reported as:: Number · percentage of participants

Incidence of Composite Cardiovascular Events
percentage of participants	Soluble Ferric Pyrophosphate	Placebo	Open-label Soluble Ferric Pyrophosphate
Incidence of Composite Cardiovascular Events	1.0	0.7	13.6

SecondaryIncidence of Hemodialysis Vascular Access Thrombotic Events

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
Reported as:: Number · percentage of participants

Incidence of Hemodialysis Vascular Access Thrombotic Events
percentage of participants	Soluble Ferric Pyrophosphate	Placebo	Open-label Soluble Ferric Pyrophosphate
Incidence of Hemodialysis Vascular Access Thrombotic Events	0.6	0.6	17.8

SecondaryIncidence of Other Thrombotic Events

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
Reported as:: Number · percentage of participants

Incidence of Other Thrombotic Events
percentage of participants	Soluble Ferric Pyrophosphate	Placebo	Open-label Soluble Ferric Pyrophosphate
Incidence of Other Thrombotic Events	0	0.1	1.9

SecondaryIncidence of Systemic/Serious Infections

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
Reported as:: Number · percentage of participants

Incidence of Systemic/Serious Infections
percentage of participants	Soluble Ferric Pyrophosphate	Placebo	Open-label Soluble Ferric Pyrophosphate
Incidence of Systemic/Serious Infections	0.4	0.9	11.3

SecondaryIncidence of Serious Adverse Events

Time frame:: Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study
Reported as:: Number · percentage of participants

Incidence of Serious Adverse Events
percentage of participants	Soluble Ferric Pyrophosphate	Placebo	Open-label Soluble Ferric Pyrophosphate
Incidence of Serious Adverse Events	4.3	5.1	46.6

Other pre-specifiedSerum Iron Change From Pre-dialysis to Post-dialysis at Week 2

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
Reported as:: Mean · micromoles per liter

Serum Iron Change From Pre-dialysis to Post-dialysis at Week 2
micromoles per liter	SFP/Placebo	Placebo/SFP
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

Other pre-specifiedSerum Iron Change From Pre-dialysis to Post-dialysis at Week 5

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
Reported as:: Mean · micromoles per liter

Serum Iron Change From Pre-dialysis to Post-dialysis at Week 5
micromoles per liter	SFP/Placebo	Placebo/SFP
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

Other pre-specifiedUnsaturated Iron-binding Capacity Change From Pre-dialysis to Post-dialysis at Week 2

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
Reported as:: Mean · micromoles per liter

Unsaturated Iron-binding Capacity Change From Pre-dialysis to Post-dialysis at Week 2
micromoles per liter	SFP/Placebo	Placebo/SFP
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

Other pre-specifiedUnsaturated Iron-binding Capacity Change From Pre-dialysis to Post-dialysis at Week 5

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
Reported as:: Mean · micromoles per liter

Unsaturated Iron-binding Capacity Change From Pre-dialysis to Post-dialysis at Week 5
micromoles per liter	SFP/Placebo	Placebo/SFP
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

Other pre-specifiedTransferrin Saturation Change From Pre-dialysis to Post-dialysis at Week 2

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
Reported as:: Mean · percent transferrin saturation

Transferrin Saturation Change From Pre-dialysis to Post-dialysis at Week 2
percent transferrin saturation	SFP/Placebo	Placebo/SFP
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

Other pre-specifiedTransferrin Saturation Change From Pre-dialysis to Post-dialysis at Week 5

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
Reported as:: Mean · percent transferrin saturation

Transferrin Saturation Change From Pre-dialysis to Post-dialysis at Week 5
percent transferrin saturation	SFP/Placebo	Placebo/SFP
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

Other pre-specifiedFerritin

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
Reported as:: Mean · micrograms per liter

Ferritin
micrograms per liter	Open-label Soluble Ferric Pyrophosphate
Baseline	653.0 ± 288.70
End of Treatment	520.3 ± 341.84
Change from Baseline	-132.0 ± 311.15

Other pre-specifiedSerum Iron

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
Reported as:: Mean · micromoles per liter

Serum Iron
micromoles per liter	Open-label Soluble Ferric Pyrophosphate
Baseline	12.650 ± 4.6488
End of Treatment	11.815 ± 5.3443
Change from Baseline	-0.772 ± 5.2686

Other pre-specifiedTransferrin Saturation

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
Reported as:: Mean · percent transferrin saturation

Transferrin Saturation
percent transferrin saturation	Open-label Soluble Ferric Pyrophosphate
Baseline	30.050 ± 10.0504
End of Treatment	28.114 ± 11.5075
Change from Baseline	-1.835 ± 11.7221

Other pre-specifiedIncidence of Patients Meeting Hy's Law Criteria

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
Reported as:: Number · participants

Incidence of Patients Meeting Hy's Law Criteria
participants	Soluble Ferric Pyrophosphate	Placebo	Open-label Soluble Ferric Pyrophosphate
Incidence of Patients Meeting Hy's Law Criteria	0	0	0

Adverse events

Collected over Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Soluble Ferric Pyrophosphate	—	30/693 (4.3%)	123/693 (17.7%)
Placebo	—	35/687 (5.1%)	131/687 (19.1%)
Open-label Soluble Ferric Pyrophosphate	—	144/309 (46.6%)	253/309 (81.9%)

Most frequent serious events

Showing 10 of 169

Most frequent serious events
Event	Soluble Ferric Pyrophosphate	Placebo	Open-label Soluble Ferric Pyrophosphate
Fluid overloadMetabolism and nutrition disorders	0/693	0/687	9/309
Gastrointestinal haemorrhageGastrointestinal disorders	0/693	0/687	8/309
PneumoniaInfections and infestations	0/693	5/687	7/309
Vascular graft thrombosisInjury, poisoning and procedural complications	1/693	1/687	7/309
HyperkalaemiaMetabolism and nutrition disorders	2/693	1/687	7/309
Cardiac failure congestiveCardiac disorders	1/693	2/687	6/309
BronchitisInfections and infestations	0/693	2/687	6/309
SepsisInfections and infestations	0/693	0/687	6/309
AnaemiaBlood and lymphatic system disorders	0/693	1/687	5/309
Acute myocardial infarctionCardiac disorders	4/693	1/687	5/309

Most frequent other events

Showing 10 of 25

Most frequent other events
Event	Soluble Ferric Pyrophosphate	Placebo	Open-label Soluble Ferric Pyrophosphate
NauseaGastrointestinal disorders	12/693	12/687	61/309
Arteriovenous fistula site complicationInjury, poisoning and procedural complications	11/693	9/687	56/309
DiarrhoeaGastrointestinal disorders	9/693	15/687	53/309
Haemodialysis-induced symptomInjury, poisoning and procedural complications	4/693	3/687	49/309
Procedural hypotensionInjury, poisoning and procedural complications	32/693	32/687	39/309
VomitingGastrointestinal disorders	8/693	8/687	37/309
DizzinessNervous system disorders	5/693	7/687	37/309
Oedema peripheralGeneral disorders	5/693	8/687	36/309
Back painMusculoskeletal and connective tissue disorders	3/693	1/687	32/309
Pain in extremityMusculoskeletal and connective tissue disorders	2/693	4/687	32/309

Baseline characteristics

All participants who received at least one dose of study drug.

Age, Continuous
Age, Continuous(years)	SFP/Placebo	Placebo/SFP	Total
Mean	59.9 ± 13.18	59.5 ± 13.30	59.7 ± 13.23

Sex: Female, Male
Sex: Female, Male(Participants)	SFP/Placebo	Placebo/SFP	Total
Female	137	141	278
Male	214	211	425

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	SFP/Placebo	Placebo/SFP	Total
Hispanic or Latino	90	106	196
Not Hispanic or Latino	261	246	507
Unknown or Not Reported	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	SFP/Placebo	Placebo/SFP	Total
American Indian or Alaska Native	5	0	5
Asian	6	8	14
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	154	145	299
White	185	194	379
More than one race	1	5	6
Unknown or Not Reported	0	0	0

Study locations

31 sites

Mobile, Alabama 36688, United States
Northridge, California 91324, United States
Arvada, Colorado 80002, United States
Westminster, Colorado 80031, United States
Lauderhill, Florida 33319, United States
Marietta, Georgia 30060, United States
Chicago, Illinois 60616, United States
Peoria, Illinois 61603, United States
Columbus, Indiana 47201, United States
Wichita, Kansas 67214, United States
Baton Rouge, Louisiana 70808, United States
Shreveport, Louisiana 71101, United States
Camp Springs, Maryland 20748, United States
Gulfport, Mississippi 39501, United States
McComb, Mississippi 39648, United States
Tupelo, Mississippi 38801, United States
St. Peters, Missouri 63376, United States
Lincoln, Nebraska 68510, United States
Reno, Nevada 89511, United States
Rocky Mount, North Carolina 27804, United States
Dayton, Ohio 45428, United States
Columbia, South Carolina 29209, United States
Research Across America
Houston, Texas 75234, United States
Houston, Texas 77051, United States
Irving, Texas 75061, United States
Mission, Texas 78572, United States
Temple, Texas 76508, United States
Tyler, Texas 75701, United States
Courtice, Ontario L1E 3C3, Canada
Montreal, Quebec H3A 1A1, Canada
Regina, Saskatchewan 54P 0W5, Canada

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 25, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01503021
Lead sponsor: Rockwell Medical Technologies, Inc.
Responsible party: Sponsor
First posted: Jan 2, 2012
Start date: Nov 2011
Primary completion: Jan 2014
Completion: Jan 2014
Results posted: Apr 21, 2015
Last update: Oct 25, 2016

Study contacts

Ray Pratt, MD

study director · Rockwell Medical, Inc

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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