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
1 other identifier
interventional
17
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 heart-failure
Started Aug 2011
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 19, 2011
CompletedFirst Posted
Study publicly available on registry
October 3, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedAugust 27, 2012
August 1, 2012
9 months
September 19, 2011
August 24, 2012
Conditions
Outcome Measures
Primary Outcomes (2)
Change from Baseline Glomerular Filtration Rate
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.
Every hour during final 6 hours of study drug infusion
Change from Baseline in Vital Signs (Blood pressure, heart rate)
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.
Baseline, during infusion, and following infusion, on Study Day 1 and Study Day 3
Study Arms (2)
TRV120027
EXPERIMENTALTRV120027 administered as an IV infusion
Normal Saline
PLACEBO COMPARATORNormal Saline administered as an IV infusion
Interventions
Eligibility Criteria
You may qualify if:
- Written Informed Consent
- Heart Failure
- Mild to moderate renal dysfunction
- Age 18- \<75
- Males and females (non-childbearing potential)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Trevena Inc.lead
Study Sites (4)
Orlando Clinical Research Center
Orlando, Florida, 32809, United States
DaVita Clinical Research
Minneapolis, Minnesota, 55404, United States
Duke Clinical Research Unit
Durham, North Carolina, 27705, United States
New Orleans Center for Clinical Research
Knoxville, Tennessee, 37920, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 19, 2011
First Posted
October 3, 2011
Study Start
August 1, 2011
Primary Completion
May 1, 2012
Study Completion
June 1, 2012
Last Updated
August 27, 2012
Record last verified: 2012-08