Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Information provided by:
Stanford University Identifier:
First received: October 13, 2005
Last updated: October 16, 2006
Last verified: June 2006

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:

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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 identifier: NCT00240019

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
Principal Investigator: Timothy W Meyer, MD Stanford University
  More Information

No publications provided 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
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Kidney Diseases
Urologic Diseases processed this record on March 01, 2015