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NCT00548249 · ClinicalTrials.gov registry record · Phase 2
Dose Ranging Study of Dialysate Containing Soluble Iron to Treat Subjects With End Stage Renal Disease (ESRD) Receiving Chronic Hemodialysis
A Phase 2 study, sponsored by Rockwell Medical Technologies.
- Completed
- Registry status
- Phase 2
- Development phase
- 131
- Enrollment target
NCT00548249: Completed Phase 2 study, sponsored by Rockwell Medical Technologies.
NCT00548249 is a Phase 2 study that has completed, run by Rockwell Medical Technologies. The registered enrollment target is 131 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00548249, a Phase 2 study, has completed, sponsored by Rockwell Medical Technologies.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 131 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether Dialysate containing soluble iron (Soluble Ferric Pyrophosphate) is safe and effective in maintaining physiological iron levels during chronic hemodialysis.
Primary Outcome
Efficacy of a Soluble Ferric Pyrophosphate (SFP)-containing dialysate solution in maintaining physiological iron levels during chronic HD, as measured by the percent of subjects whose hgb decreases by a total of 1.0 g/dL (or more) from baseline on each of two successive measurements. Hemoglobin was obtained weekly at the mid-week dialysis treatments and compared to baseline value (average of two hgb measurements obtained at the two consecutive baseline visits prior to randomization).
Interventions
- DEVICE Standard Bicarbonate Solution
- DRUG Soluble Ferric Pyrophosphate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 131 participants |
| Start Date | 2007-08 |
| Est. Completion | 2010-01 |
| Phase | Phase 2 |
What the finished NCT00548249 record still lists
NCT00548249 is an interventional study that assigns participants to a tested intervention. The registered 131 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Standard Bicarbonate Solution is the first listed.
NCT00548249 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00548249 about?
NCT00548249 is a clinical study titled "Dose Ranging Study of Dialysate Containing Soluble Iron to Treat Subjects With End Stage Renal Disease (ESRD) Receiving Chronic Hemodialysis". The purpose of this study is to determine whether Dialysate containing soluble iron (Soluble Ferric Pyrophosphate) is safe and effective in maintaining physiological iron levels during chronic hemodialysis.
What is the current status of trial NCT00548249?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 131 participants. The study started on 2007-08. Estimated completion is 2010-01.
What interventions are being tested in trial NCT00548249?
The interventions under investigation include: Standard Bicarbonate Solution (DEVICE), Soluble Ferric Pyrophosphate (DRUG).
Who is sponsoring clinical trial NCT00548249?
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 NCT00548249's enrollment target sits among peer trials
131 541st of 2000 higher than 1,458 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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