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

History of Changes

Tracking Information
First Received Date ^ICMJE	September 19, 2011
Last Updated Date	August 24, 2012
Start Date ^ICMJE	August 2011
Primary Completion Date	May 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 29, 2011)	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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01444872 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Study to Evaluate TRV120027 on Renal Pharmacodynamics in Patients With Heart Failure and Renal Dysfunction
Official Title ^ICMJE	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
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Crossover Assignment Masking: Single Blind (Subject)
Condition ^ICMJE	Heart Failure Kidney Disease
Intervention ^ICMJE	Drug: TRV120027 IV infusion Drug: Normal Saline IV infusion
Study Arm (s)	Experimental: TRV120027 TRV120027 administered as an IV infusion Intervention: Drug: TRV120027 Placebo Comparator: Normal Saline Normal Saline administered as an IV infusion Intervention: Drug: Normal Saline
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	17
Completion Date	June 2012
Primary Completion Date	May 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 74 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01444872
Other Study ID Numbers ^ICMJE	CP120027.1002
Has Data Monitoring Committee	Not Provided
Responsible Party	Trevena Inc.
Study Sponsor ^ICMJE	Trevena Inc.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Trevena Inc.
Verification Date	August 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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