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Completed

NCT Number: NCT01444872

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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Diseases Kidney Disease Kidney Diseases Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Orlando Clinical Research Center, Orlando, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TRV120027

Drug

IV infusion

normal saline

Drug

IV infusion

Primary outcomes

  1. Change from Baseline Glomerular Filtration Rate

    Time frame: 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.

  2. Change from Baseline in Vital Signs (Blood pressure, heart rate)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Trevena Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 3, 2011
Registry last updated
Aug 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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