Study to Evaluate TRV120027 on Renal Pharmacodynamics in Patients With Heart Failure and Renal Dysfunction
This study has been completed.
Sponsor:
Trevena Inc.
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
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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
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 Heart Diseases Cardiovascular Diseases Urologic Diseases |
ClinicalTrials.gov processed this record on June 18, 2013