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NCT01320202 · ClinicalTrials.gov registry record · Phase 3
Continuous Soluble Ferric Pyrophosphate (SFP) Iron Delivery Via Dialysate in Hemodialysis Patients
A Phase 3 study, sponsored by Rockwell Medical Technologies.
- Completed
- Registry status
- Phase 3
- Development phase
- 305
- Enrollment target
NCT01320202: Completed Phase 3 study, sponsored by Rockwell Medical Technologies.
NCT01320202 is a Phase 3 study that has completed, run by Rockwell Medical Technologies. The registered enrollment target is 305 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01320202, a Phase 3 study, has completed, sponsored by Rockwell Medical Technologies.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 305 participants
- Enrollment target
Study Summary
The purpose of this study is to confirm the safety and efficacy of Soluble Ferric Pyrophosphate (SFP) dialysate solution in maintaining iron delivery for erythropoiesis in anemic adult patients with chronic kidney disease (CKD) receiving hemodialysis. Efficacy will be measured primarily by the change from baseline in hemoglobin (Hgb).
Primary Outcome
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.
Interventions
- DRUG Soluble Ferric Pyrophosphate (SFP)
- DEVICE Standard dialysate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 305 participants |
| Start Date | 2011-03 |
| Est. Completion | 2013-11 |
| Phase | Phase 3 |
What the finished NCT01320202 record still lists
NCT01320202 is an interventional study that assigns participants to a tested intervention. The registered 305 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 2 interventions - of which Soluble Ferric Pyrophosphate (SFP) is the first listed.
NCT01320202 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01320202 about?
NCT01320202 is a clinical study titled "Continuous Soluble Ferric Pyrophosphate (SFP) Iron Delivery Via Dialysate in Hemodialysis Patients". The purpose of this study is to confirm the safety and efficacy of Soluble Ferric Pyrophosphate (SFP) dialysate solution in maintaining iron delivery for erythropoiesis in anemic adult patients with chronic kidney disease (CKD) receiving hemodialysis. Efficacy will be measured primarily by the chang...
What is the current status of trial NCT01320202?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 305 participants. The study started on 2011-03. Estimated completion is 2013-11.
What interventions are being tested in trial NCT01320202?
The interventions under investigation include: Soluble Ferric Pyrophosphate (SFP) (DRUG), Standard dialysate (DEVICE).
Who is sponsoring clinical trial NCT01320202?
This trial is sponsored by Rockwell Medical Technologies, which has 15 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01320202's enrollment target sits among peer trials
305 1117th of 2000 higher than 884 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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