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

This study has been completed.

First Received on October 13, 2005. Last Updated on October 16, 2006 History of Changes

Sponsor:	Stanford University
Collaborator:	National Institutes of Health (NIH)
Information provided by:	Stanford University
ClinicalTrials.gov Identifier:	NCT00240019

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 Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Maximizing the Benefit of RAS Blockade in Diabetic Nephropathy

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetic Kidney Problems Urine and Urination

Drug Information available for: Furosemide BaseLine

U.S. FDA Resources

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

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
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

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

No publications provided

ClinicalTrials.gov Identifier:	NCT00240019 History of Changes
Other Study ID Numbers:	R01-063011, R01 DK063011
Study First Received:	October 13, 2005
Last Updated:	October 16, 2006
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Diabetic Nephropathies
Kidney Diseases
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Furosemide
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