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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Trevena Inc.
ClinicalTrials.gov Identifier:
NCT01444872
First received: September 19, 2011
Last updated: August 24, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Heart Failure
Kidney Disease
Drug: TRV120027
Drug: Normal Saline
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Trevena Inc.:

Primary Outcome Measures:
  • Change from Baseline Glomerular Filtration Rate [ Time Frame: Every hour during final 6 hours of study drug infusion ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline, during infusion, and following infusion, on Study Day 1 and Study Day 3 ] [ Designated as safety issue: No ]
    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.


Enrollment: 17
Study Start Date: August 2011
Study Completion Date: June 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TRV120027
TRV120027 administered as an IV infusion
Drug: TRV120027
IV infusion
Placebo Comparator: Normal Saline
Normal Saline administered as an IV infusion
Drug: Normal Saline
IV infusion

  Eligibility

Ages Eligible for Study:   18 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01444872

Locations
United States, Florida
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
United States, Minnesota
DaVita Clinical Research
Minneapolis, Minnesota, United States, 55404
United States, North Carolina
Duke Clinical Research Unit
Durham, North Carolina, United States, 27705
United States, Tennessee
New Orleans Center for Clinical Research
Knoxville, Tennessee, United States, 37920
Sponsors and Collaborators
Trevena Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Trevena Inc.
ClinicalTrials.gov Identifier: NCT01444872     History of Changes
Other Study ID Numbers: CP120027.1002
Study First Received: September 19, 2011
Last Updated: August 24, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Heart Failure
Kidney Diseases
Cardiovascular Diseases
Heart Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on November 25, 2014