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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01444872
Recruitment Status : Completed
First Posted : October 3, 2011
Last Update Posted : August 27, 2012
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Heart Failure Kidney Disease Drug: TRV120027 Drug: Normal Saline Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
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
Study Start Date : August 2011
Primary Completion Date : May 2012
Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.

Additional Information:
Responsible Party: Trevena Inc.
ClinicalTrials.gov Identifier: NCT01444872     History of Changes
Other Study ID Numbers: CP120027.1002
First Posted: October 3, 2011    Key Record Dates
Last Update Posted: August 27, 2012
Last Verified: August 2012

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