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NCT02595437 · ClinicalTrials.gov registry record · Phase 1
Triferic Pediatric Pharmacokinetic Protocol
A Phase 1 study, sponsored by Rockwell Medical Technologies.
- Completed
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
NCT02595437: Completed Phase 1 study, sponsored by Rockwell Medical Technologies.
NCT02595437 is a Phase 1 study that has completed, run by Rockwell Medical Technologies. The registered enrollment target is 22 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02595437, a Phase 1 study, has completed, sponsored by Rockwell Medical Technologies.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
Study Summary
The main purpose is to determine the pharmacokinetics (PK) of Triferic iron administered intravenously in pediatric patients with chronic kidney disease on chronic hemodialysis (CKD-5HD). It is an open-label, two-period sequential dosing study.
Primary Outcome
The PK will be done by assessing the mean absolute and baseline-corrected Cmax of total iron with an IV infusion of Triferic at 0.07 mg iron/kg during a single dialysis session. The absolute Cmax includes the concentration of iron that was present in the serum prior to dosing as well the iron administered, while the baseline-corrected Cmax factors out the iron present in the serum prior to dosing and includes the administered iron only.
Interventions
- DRUG Triferic
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2015-11-01 |
| Est. Completion | 2017-01 |
| Phase | Phase 1 |
What the finished NCT02595437 record still lists
NCT02595437 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 1 intervention - of which Triferic is the first listed.
NCT02595437 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02595437 about?
NCT02595437 is a clinical study titled "Triferic Pediatric Pharmacokinetic Protocol". The main purpose is to determine the pharmacokinetics (PK) of Triferic iron administered intravenously in pediatric patients with chronic kidney disease on chronic hemodialysis (CKD-5HD). It is an open-label, two-period sequential dosing study.
What is the current status of trial NCT02595437?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2015-11-01. Estimated completion is 2017-01.
What interventions are being tested in trial NCT02595437?
The interventions under investigation include: Triferic (DRUG).
Who is sponsoring clinical trial NCT02595437?
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 NCT02595437's enrollment target sits among peer trials
22 1601st of 2000 higher than 386 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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