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

This study has been completed.

First Received on September 7, 2005. Last Updated on January 28, 2008 History of Changes

Sponsor:	NovaCardia, Inc.
Collaborator:	Merck
Information provided by:	NovaCardia, Inc.
ClinicalTrials.gov Identifier:	NCT00159614

Purpose

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

Condition	Intervention	Phase
Heart Failure, Congestive Renal Insufficiency	Drug: KW-3902IV	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Effect of KW-3902IV in Combination With IV Furosemide on Renal Function in Subjects With Congestive Heart Failure (CHF) and Renal Impairment

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

Drug Information available for: Furosemide 1,3-Dipropyl-8-(3-noradamantyl)xanthine

U.S. FDA Resources

Further study details as provided by NovaCardia, Inc.:

Primary Outcome Measures:

Comparison of KW-3902IV alone or with loop diuretic on renal function.

Estimated Enrollment:	30
Study Start Date:	September 2005

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00159614

Locations

United States, California

San Diego, California, United States
United States, Maryland

Baltimore, Maryland, United States
United States, Massachusetts

Ayer, Massachusetts, United States

Boston, Massachusetts, United States
United States, Michigan

Kalamazoo, Michigan, United States
United States, Tennessee

Tullahoma, Tennessee, United States

Sponsors and Collaborators

NovaCardia, Inc.

Merck

More Information

No publications provided by NovaCardia, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

ClinicalTrials.gov Identifier:	NCT00159614 History of Changes
Other Study ID Numbers:	CKI-203
Study First Received:	September 7, 2005
Last Updated:	January 28, 2008
Health Authority:	United States: Food and Drug Administration

Keywords provided by NovaCardia, Inc.:

renal insufficiency
diuretic
heart failure, congestive

Additional relevant MeSH terms:

Heart Failure
Renal Insufficiency
Heart Diseases
Cardiovascular Diseases
Kidney Diseases
Urologic Diseases
Furosemide
1,3-dipropyl-8-(3-noradamantyl)xanthine
Sodium Potassium Chloride Symporter Inhibitors

Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 12, 2012