Study to Evaluate TRV120027 on Renal Pharmacodynamics in Patients With Heart Failure and Renal Dysfunction

Completed · Phase 1

Conditions studied: Heart Failure, Kidney Disease

In brief

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.

Key facts

Study ID

NCT01444872

Run by

Trevena Inc.

People needed

17

Starts

2011-08-01

Expected to finish

2012-06-01

Last updated by the study team

2012-08-27

Who can join

Age: 18 and older, up to 74. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Written Informed Consent
• Heart Failure
• Mild to moderate renal dysfunction
• Age 18- <75
• Males and females (non-childbearing potential)

You may not qualify if…

• Any significant disease or condition that would interfere with the interpretation of safety or efficacy or efficacy data as determined by the Investigator based on medical history, physical examination or laboratory tests
• Any other serious life threatening disease that may impair the interpretation of safety or efficacy data from the study as determined by the Investigator
• Allergy or clinically-significant intolerance to ARBs or ACE inhibitors
• Clinical signs or symptoms of acute decompensated heart failure
• Pregnant or lactating

Where it is running

• Orlando Clinical Research Center — Orlando, Florida, United States
• DaVita Clinical Research — Minneapolis, Minnesota, United States
• Duke Clinical Research Unit — Durham, North Carolina, United States
• New Orleans Center for Clinical Research — Knoxville, Tennessee, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.