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Maximizing the Benefit of Renin-Angiotensin Blocking Drugs in Diabetic Renal Disease.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00240019
First Posted: October 17, 2005
Last Update Posted: October 17, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institutes of Health (NIH)
Information provided by:
Stanford University
  Purpose
The angiotensin converting enzyme inhibitor drugs are now standard therapy for patients with diabetic nephropathy. The hypothesis of this study is that adding a diuretic agent (furosemide) will decrease the urine protein, which is a sign of disease, more than an angiotensin converting enzyme inhibitor alone.

Condition Intervention
Diabetic Nephropathy Drug: Addition of furosemide 20 mg oral bid to baseline regimen

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Maximizing the Benefit of RAS Blockade in Diabetic Nephropathy

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • The amount of protein in the urine after 8 weeks of treatment.

Secondary Outcome Measures:
  • The estimated glomerular filtration rate after 8 weeks of treatment.

Estimated Enrollment: 30
Study Start Date: December 2003
Estimated Study Completion Date: April 2006
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

proteinuria greater than 1 gram/day serum creatinine < 2.6 for men, < 2.0 for women

Exclusion Criteria:

blood pressure which cannot be controlled without a diuretic renal diseases other than diabetic nephropathy other disease which would alter renal function during 6 months

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00240019


Locations
United States, California
Kaiser Permanente of Northern California, Santa Clara and San Jose
Santa Clara, California, United States, 95051
Stanford University Medical Center
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
National Institutes of Health (NIH)
Investigators
Principal Investigator: Timothy W Meyer, MD Stanford University
  More Information

ClinicalTrials.gov Identifier: NCT00240019     History of Changes
Other Study ID Numbers: R01-063011
R01DK063011 ( U.S. NIH Grant/Contract )
First Submitted: October 13, 2005
First Posted: October 17, 2005
Last Update Posted: October 17, 2006
Last Verified: June 2006

Additional relevant MeSH terms:
Kidney Diseases
Diabetic Nephropathies
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Furosemide
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action