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NCT01444872 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate TRV120027 on Renal Pharmacodynamics in Patients With Heart Failure and Renal Dysfunction
A Phase 1 study of Heart Failure and Kidney Disease, sponsored by Trevena.
- Completed
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
- 4
- Study locations
NCT01444872: Completed Phase 1 study of Heart Failure and Kidney Disease, sponsored by Trevena.
NCT01444872 is a Phase 1 study of Heart Failure and Kidney Disease that has completed, run by Trevena. The registered enrollment target is 17 participants, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (99% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01444872, a Phase 1 study of Heart Failure and Kidney Disease, has completed, sponsored by Trevena.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
- 4
- Study locations
Study Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of TRV120027 in subjects with heart failure and mild to moderate renal dysfunction.
Primary Outcome
Assessments of glomerular filtration rate are made hourly during the 6-hour study drug infusion on study Day 1 and study Day 3. GFR in hours 4-6 are compared to GFR in hours 1-3, and comparisons made between Placebo and TRV120027.
Conditions Studied
Interventions
- DRUG Normal Saline
- DRUG TRV120027
Study Locations (4)
Florida
- Orlando Clinical Research Center - Orlando
Minnesota
- DaVita Clinical Research - Minneapolis
North Carolina
- Duke Clinical Research Unit - Durham
Tennessee
- New Orleans Center for Clinical Research - Knoxville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2011-08 |
| Est. Completion | 2012-06 |
| Phase | Phase 1 |
What the finished NCT01444872 record still lists
NCT01444872 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Heart Failure appearing as the primary indexed condition, and to 2 interventions - of which Normal Saline is the first listed.
NCT01444872 reports a single indexed study location in Florida, Minnesota, North Carolina.
Frequently Asked Questions
What is clinical trial NCT01444872 about?
NCT01444872 is a clinical study titled "Study to Evaluate TRV120027 on Renal Pharmacodynamics in Patients With Heart Failure and Renal Dysfunction". The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of TRV120027 in subjects with heart failure and mild to moderate renal dysfunction.
What is the current status of trial NCT01444872?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2011-08. Estimated completion is 2012-06.
What conditions does trial NCT01444872 study?
This clinical trial studies the following conditions: Heart Failure, Kidney Disease.
What interventions are being tested in trial NCT01444872?
The interventions under investigation include: Normal Saline (DRUG), TRV120027 (DRUG).
Who is sponsoring clinical trial NCT01444872?
This trial is sponsored by Trevena, which has 15 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01444872 being conducted?
This trial has 4 study locations across Florida, Minnesota, North Carolina, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Heart Failure
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01444872's enrollment target sits among peer trials
17 366th of 397 higher than 30 of 397 other Heart Failure trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Heart Failure 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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