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NCT02739100 · ClinicalTrials.gov registry record · Phase 1

Pharmacokinetics and Preliminary Bioequivalence of Triferic (Ferric Pyrophosphate Citrate) Administered Via Hemodialysate and Intravenously to Adult CKD-5HD Patients

A Phase 1 study, sponsored by Rockwell Medical Technologies.

Completed
Registry status
Phase 1
Development phase
13
Enrollment target

NCT02739100: Completed Phase 1 study, sponsored by Rockwell Medical Technologies.

NCT02739100 is a Phase 1 study that has completed, run by Rockwell Medical Technologies. The registered enrollment target is 13 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02739100, a Phase 1 study, has completed, sponsored by Rockwell Medical Technologies.

COMPLETED
Registry status
Phase 1
Development phase
13 participants
Enrollment target

Study Summary

The main purpose is to determine the pharmacokinetics (PK) of Triferic iron administered via hemodialysate and via two different intravenous routes in adult patients with chronic kidney disease on chronic hemodialysis (CKD-5HD). It is an open-label, randomized single dose study.

Primary Outcome

The PK will be done by assessing the mean Cmax of total serum iron from Triferic administered via hemodialysate, compared to Triferic administered at a fixed IV dose of 6.6 mg iron/kg during a single dialysis session.

Interventions

  • DRUG Triferic

Trial Details

FieldValue
Enrollment Target 13 participants
Start Date 2016-04
Est. Completion 2016-07
Phase Phase 1
Rockwell Medical Technologies

15 total trials

What the finished NCT02739100 record still lists

NCT02739100 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower).

The record links to 0 conditions, and to 1 intervention - of which Triferic is the first listed.

NCT02739100 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02739100 about?

NCT02739100 is a clinical study titled "Pharmacokinetics and Preliminary Bioequivalence of Triferic (Ferric Pyrophosphate Citrate) Administered Via Hemodialysate and Intravenously to Adult CKD-5HD Patients". The main purpose is to determine the pharmacokinetics (PK) of Triferic iron administered via hemodialysate and via two different intravenous routes in adult patients with chronic kidney disease on chronic hemodialysis (CKD-5HD). It is an open-label, randomized single dose study.

What is the current status of trial NCT02739100?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2016-04. Estimated completion is 2016-07.

What interventions are being tested in trial NCT02739100?

The interventions under investigation include: Triferic (DRUG).

Who is sponsoring clinical trial NCT02739100?

This trial is sponsored by Rockwell Medical Technologies, which has 15 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02739100's enrollment target sits among peer trials

13 1847th of 2000 higher than 149 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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Source: ClinicalTrials.gov NCT02739100, the US trial registry maintained by the National Library of Medicine. NCT02739100 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.