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

Phase 1

Completed

• Conditions: Heart Failure; Kidney Disease
• Interventions: Drug: TRV120027; Drug: Normal Saline

• Registration Number: NCT01444872
• Lead Sponsor: Trevena Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-09-19
• Study First Submitted QC: 2011-09-29
• Study First Posted: 2011-10-03
• Primary Completion: 2012-05
• Study Completion: 2012-06
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-24
• Last Update Posted: 2012-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
TRV120027	TRV120027	TRV120027 administered as an IV infusion
Normal Saline	Normal Saline	Normal Saline administered as an IV infusion

Primary Outcome Measures

Name	Time	Method
Change from Baseline Glomerular Filtration Rate	Every hour during final 6 hours of study drug infusion	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.
Change from Baseline in Vital Signs (Blood pressure, heart rate)	Baseline, during infusion, and following infusion, on Study Day 1 and Study Day 3	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.

Trial Locations

Locations (4)

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