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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01444872

Enrollment

Registered

2011-10-03

Start date

2011-08-31

Completion date

2012-06-30

Last updated

2012-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, Kidney Disease

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.

Interventions

DRUGTRV120027

IV infusion

DRUGNormal Saline

IV infusion

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 74 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026