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NCT01503021 · ClinicalTrials.gov registry record · Phase 3
Safety Study of Soluble Ferric Pyrophosphate (SFP) in Dialysate in CKD Patients Receiving Chronic Hemodialysis
A Phase 3 study, sponsored by Rockwell Medical Technologies.
- Completed
- Registry status
- Phase 3
- Development phase
- 718
- Enrollment target
NCT01503021: Completed Phase 3 study, sponsored by Rockwell Medical Technologies.
NCT01503021 is a Phase 3 study that has completed, run by Rockwell Medical Technologies. The registered enrollment target is 718 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01503021, a Phase 3 study, has completed, sponsored by Rockwell Medical Technologies.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 718 participants
- Enrollment target
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.
Primary Outcome
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.
Interventions
- OTHER Placebo
- DRUG SFP
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 718 participants |
| Start Date | 2011-11 |
| Est. Completion | 2014-01 |
| Phase | Phase 3 |
What the finished NCT01503021 record still lists
NCT01503021 is an interventional study that assigns participants to a tested intervention. The registered 718 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01503021 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01503021 about?
NCT01503021 is a clinical study titled "Safety Study of Soluble Ferric Pyrophosphate (SFP) in Dialysate in CKD Patients Receiving Chronic Hemodialysis". 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...
What is the current status of trial NCT01503021?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 718 participants. The study started on 2011-11. Estimated completion is 2014-01.
What interventions are being tested in trial NCT01503021?
The interventions under investigation include: Placebo (OTHER), SFP (DRUG).
Who is sponsoring clinical trial NCT01503021?
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 NCT01503021's enrollment target sits among peer trials
718 498th of 2000 higher than 1,503 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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