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NCT01131845 · ClinicalTrials.gov registry record · Phase 1
The Effect of Renal Impairment on the Pharmacokinetics of Oral Treprostinil
A Phase 1 study, sponsored by United Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT01131845: Completed Phase 1 study, sponsored by United Therapeutics.
NCT01131845 is a Phase 1 study that has completed, run by United Therapeutics. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01131845, a Phase 1 study, has completed, sponsored by United Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
This is a single-center, open-label, single-dose evaluation of 1 mg UT-15C SR pharmacokinetics, safety, and tolerability in subjects with normal, mild, moderate and end stage renal disease (ESRD; on dialysis). Subjects in the ESRD group will receive 2 doses of UT-15C SR, separated by 14 days. One dose will be given 4 hours prior to dialysis, the other dose will be given at the end of dialysis. Pharmacokinetic samples will be taken immediately prior to dosing and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 24, 30, 36, 42 and 48 hours post dose. Additionally, subjects with ESRD will have a sample taken at 60 hrs post dose.
Interventions
- DRUG UT-15C SR (treprostinil diethanolamine)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2010-05 |
| Est. Completion | 2010-09 |
| Phase | Phase 1 |
What the finished NCT01131845 record still lists
NCT01131845 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 1 intervention - of which UT-15C SR (treprostinil diethanolamine) is the first listed.
NCT01131845 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01131845 about?
NCT01131845 is a clinical study titled "The Effect of Renal Impairment on the Pharmacokinetics of Oral Treprostinil". This is a single-center, open-label, single-dose evaluation of 1 mg UT-15C SR pharmacokinetics, safety, and tolerability in subjects with normal, mild, moderate and end stage renal disease (ESRD; on dialysis). Subjects in the ESRD group will receive 2 doses of UT-15C SR, separated by 14 days. One d...
What is the current status of trial NCT01131845?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2010-05. Estimated completion is 2010-09.
What interventions are being tested in trial NCT01131845?
The interventions under investigation include: UT-15C SR (treprostinil diethanolamine) (DRUG).
Who is sponsoring clinical trial NCT01131845?
This trial is sponsored by United Therapeutics, which has 63 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01131845's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 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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