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

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
NovaCardia, Inc.
ClinicalTrials.gov Identifier:
NCT00159614
First received: September 7, 2005
Last updated: January 28, 2008
Last verified: January 2008
  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 2

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Sharp & Dohme Corp.
  More Information

No publications provided by NovaCardia, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
1,3-dipropyl-8-(3-noradamantyl)xanthine
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014