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

Heart Failure Clinical Trial

Official title:

A Randomized, Single-Blind, Placebo-Controlled, Adaptive, Ascending Dose Study to Evaluate the Effects of TRV120027 on Renal Pharmacodynamics in Patients With Heart Failure and Mild to Moderate Renal Dysfunction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01444872
• Other study ID #: CP120027.1002
• Status: Completed
• Phase: Phase 1
• First received: September 19, 2011
• Last updated: August 24, 2012
• Start date: August 2011
• Est. completion date: June 2012

Study information

• Verified date: August 2012
• Source: Trevena Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: June 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 74 Years

Eligibility

Inclusion Criteria:

• Written Informed Consent

• Heart Failure

• Mild to moderate renal dysfunction

• Age 18- <75

• Males and females (non-childbearing potential)

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Heart Failure
• Kidney Disease
• Kidney Diseases
• Renal Insufficiency

Intervention

Drug:
• TRV120027
IV infusion
• Normal Saline
IV infusion

Locations

Country	Name	City	State
United States	Duke Clinical Research Unit	Durham	North Carolina
United States	New Orleans Center for Clinical Research	Knoxville	Tennessee
United States	DaVita Clinical Research	Minneapolis	Minnesota
United States	Orlando Clinical Research Center	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Trevena Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Glomerular Filtration Rate	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.	Every hour during final 6 hours of study drug infusion	No
Primary	Change from Baseline in Vital Signs (Blood pressure, heart rate)	Vital signs measurements made during and following drug infusion will be evaluated as a change from baseline, and comparing placebo to TRV120027. Assessments are made on study Day 1 and study Day 3.	Baseline, during infusion, and following infusion, on Study Day 1 and Study Day 3	No

External Links

•   Sponsor's Website