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NCT01920854 · ClinicalTrials.gov registry record · Phase 1
A Single Ascending Dose Study of Soluble Ferric Pyrophosphate Administered Intravenously in Healthy Volunteers.
A Phase 1 study of Kidney Failure, Chronic Therapy; Hemodialysis, sponsored by Rockwell Medical Technologies.
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
- 1
- Study location
NCT01920854: Completed Phase 1 study of Kidney Failure, Chronic Therapy; Hemodialysis, sponsored by Rockwell Medical Technologies.
NCT01920854 is a Phase 1 study of Kidney Failure, Chronic Therapy; Hemodialysis that has completed, run by Rockwell Medical Technologies. The registered enrollment target is 48 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01920854, a Phase 1 study of Kidney Failure, Chronic Therapy; Hemodialysis, has completed, sponsored by Rockwell Medical Technologies.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to determine the pharmacokinetics of fixed ascending doses of intravenously administered Soluble Ferric Pyrophosphate
Primary Outcome
Serum iron for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Serum iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive stat
Conditions Studied
Interventions
- DRUG Placebo
- DRUG soluble ferric pyrophosphate
Study Locations (1)
Michigan
- - Kalamazoo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2013-06 |
| Est. Completion | 2013-09 |
| Phase | Phase 1 |
What the finished NCT01920854 record still lists
NCT01920854 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower).
The record links to 1 condition, with Kidney Failure, Chronic Therapy; Hemodialysis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01920854 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT01920854 about?
NCT01920854 is a clinical study titled "A Single Ascending Dose Study of Soluble Ferric Pyrophosphate Administered Intravenously in Healthy Volunteers.". The purpose of this study is to determine the pharmacokinetics of fixed ascending doses of intravenously administered Soluble Ferric Pyrophosphate
What is the current status of trial NCT01920854?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2013-06. Estimated completion is 2013-09.
What conditions does trial NCT01920854 study?
This clinical trial studies the following conditions: Kidney Failure, Chronic Therapy; Hemodialysis.
What interventions are being tested in trial NCT01920854?
The interventions under investigation include: Placebo (DRUG), soluble ferric pyrophosphate (DRUG).
Who is sponsoring clinical trial NCT01920854?
This trial is sponsored by Rockwell Medical Technologies, which has 15 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01920854 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01920854's enrollment target sits among peer trials
48 1025th of 2000 higher than 948 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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