Back to resultsEffect of KW-3902IV in Combination With IV Furosemide on Renal Function in Subjects With CHF and Renal Impairment
Primary Purpose
Heart Failure, Congestive, Renal Insufficiency
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
KW-3902IV
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure, Congestive focused on measuring renal insufficiency, diuretic, heart failure, congestive
Eligibility Criteria
Inclusion Criteria: Stable congestive heart failure Impaired renal function Taking oral loop diuretic Exclusion Criteria: Acutely decompensated (unstable) and end stage heart failure Diuretics other than loop diuretics Pregnant or nursing Inability to follow instructions Participation in another clinical trial within past 30 days
Sites / Locations
Outcomes
Primary Outcome Measures
Comparison of KW-3902IV alone or with loop diuretic on renal function.
Secondary Outcome Measures
Full Information
NCT ID
NCT00159614
First Posted
September 7, 2005
Last Updated
January 28, 2008
Sponsor
NovaCardia, Inc.
Collaborators
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00159614
Brief Title
Effect of KW-3902IV in Combination With IV Furosemide on Renal Function in Subjects With CHF and Renal Impairment
Official Title
Effect of KW-3902IV in Combination With IV Furosemide on Renal Function in Subjects With Congestive Heart Failure (CHF) and Renal Impairment
Study Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
NovaCardia, Inc.
Collaborators
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to characterize the safety and tolerability of KW-3902IV and measure its effect on renal function.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Congestive, Renal Insufficiency
Keywords
renal insufficiency, diuretic, heart failure, congestive
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
30 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
KW-3902IV
Primary Outcome Measure Information:
Title
Comparison of KW-3902IV alone or with loop diuretic on renal function.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Stable congestive heart failure
Impaired renal function
Taking oral loop diuretic
Exclusion Criteria:
Acutely decompensated (unstable) and end stage heart failure
Diuretics other than loop diuretics
Pregnant or nursing
Inability to follow instructions
Participation in another clinical trial within past 30 days
Facility Information:
City
San Diego
State/Province
California
Country
United States
City
Baltimore
State/Province
Maryland
Country
United States
City
Ayer
State/Province
Massachusetts
Country
United States
City
Boston
State/Province
Massachusetts
Country
United States
City
Kalamazoo
State/Province
Michigan
Country
United States
City
Tullahoma
State/Province
Tennessee
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
17923351
Citation
Dittrich HC, Gupta DK, Hack TC, Dowling T, Callahan J, Thomson S. The effect of KW-3902, an adenosine A1 receptor antagonist, on renal function and renal plasma flow in ambulatory patients with heart failure and renal impairment. J Card Fail. 2007 Oct;13(8):609-17. doi: 10.1016/j.cardfail.2007.08.006.
Results Reference
derived
Learn more about this trial
Effect of KW-3902IV in Combination With IV Furosemide on Renal Function in Subjects With CHF and Renal Impairment
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