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NCT00159614 Clinical Trial

Effect of KW-3902IV in Combination With IV Furosemide on Renal Function in Subjects With CHF and Renal Impairment

Renal Insufficiency Clinical Trial

Official title:
Effect of KW-3902IV in Combination With IV Furosemide on Renal Function in Subjects With Congestive Heart Failure (CHF) and Renal Impairment

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00159614
Other study ID # CKI-203
Secondary ID
Status Completed
Phase Phase 2
First received September 7, 2005
Last updated January 28, 2008
Start date September 2005

Study information
Verified date January 2008
Source NovaCardia, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to characterize the safety and tolerability of KW-3902IV and measure its effect on renal function.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• KW-3902IV

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
NovaCardia, Inc. Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Comparison of KW-3902IV alone or with loop diuretic on renal function.
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