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

Trevena Inc.17 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

SINGLE

Enrollment

Conditions

Heart Failure Kidney Disease

Interventions

TRV120027DRUG

IV infusion

Normal SalineDRUG

IV infusion

Eligibility

Sex: ALLMin age: 18 YearsMax age: 74 Years

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

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.

Time frame: Every hour during final 6 hours of study drug infusion

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.

Time frame: Baseline, during infusion, and following infusion, on Study Day 1 and Study Day 3

Data from ClinicalTrials.gov

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