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NCT01286012 · ClinicalTrials.gov registry record · Phase 2
Continuous Soluble Ferric Pyrophosphate (SFP) Iron Delivery Via Dialysate in Hemodialysis Patients
A Phase 2 study, sponsored by Rockwell Medical Technologies.
- Completed
- Registry status
- Phase 2
- Development phase
- 108
- Enrollment target
NCT01286012: Completed Phase 2 study, sponsored by Rockwell Medical Technologies.
NCT01286012 is a Phase 2 study that has completed, run by Rockwell Medical Technologies. The registered enrollment target is 108 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (19% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01286012, a Phase 2 study, has completed, sponsored by Rockwell Medical Technologies.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 108 participants
- Enrollment target
Study Summary
The purpose of this study is to compare the clinical safety and efficacy of SFP in sparing the need for erythropoiesis stimulating agents (ESAs) required to maintain hemoglobin (hgb) levels in chronic hemodialysis subjects who receive SFP via the dialysate versus subjects who receive conventional dialysate without iron.
Primary Outcome
The statistical endpoint is the change from baseline between groups at End of Treatment, where the baseline prescribed ESA dose (expressed as U/week epoetin) per subject is defined as the average weekly dose of ESA prescribed for administration over the two-week period of time immediately prior to randomization. The end-of-treatment prescribed ESA dose (expressed as U/week epoetin) per subject is defined as the average weekly dose of ESA prescribed for administration over the last two weeks of t
Interventions
- DRUG Soluble Ferric Pyrophosphate in liquid bicarbonate
- DRUG Placebo: Conventional liquid bicarbonate
- DRUG Erythrocyte Stimulating Agent (ESA)
- DRUG Intravenous (IV) Iron
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 108 participants |
| Start Date | 2011-01 |
| Est. Completion | 2013-01 |
| Phase | Phase 2 |
What the finished NCT01286012 record still lists
NCT01286012 is an interventional study that assigns participants to a tested intervention. The registered 108 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (19% lower).
The record links to 0 conditions, and to 4 interventions - of which Soluble Ferric Pyrophosphate in liquid bicarbonate is the first listed.
NCT01286012 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01286012 about?
NCT01286012 is a clinical study titled "Continuous Soluble Ferric Pyrophosphate (SFP) Iron Delivery Via Dialysate in Hemodialysis Patients". The purpose of this study is to compare the clinical safety and efficacy of SFP in sparing the need for erythropoiesis stimulating agents (ESAs) required to maintain hemoglobin (hgb) levels in chronic hemodialysis subjects who receive SFP via the dialysate versus subjects who receive conventional di...
What is the current status of trial NCT01286012?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 108 participants. The study started on 2011-01. Estimated completion is 2013-01.
What interventions are being tested in trial NCT01286012?
The interventions under investigation include: Soluble Ferric Pyrophosphate in liquid bicarbonate (DRUG), Placebo: Conventional liquid bicarbonate (DRUG), Erythrocyte Stimulating Agent (ESA) (DRUG), Intravenous (IV) Iron (DRUG).
Who is sponsoring clinical trial NCT01286012?
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 NCT01286012's enrollment target sits among peer trials
108 640th of 2000 higher than 1,355 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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