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

Diabetic Nephropathy Clinical Trial

Official title:

Maximizing the Benefit of RAS Blockade in Diabetic Nephropathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00240019
• Other study ID #: R01-063011
• Secondary ID: R01DK063011
• Status: Completed
• Phase: N/A
• First received: October 13, 2005
• Last updated: October 16, 2006
• Start date: December 2003
• Est. completion date: April 2006

Study information

• Verified date: June 2006
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Nephropathies
• Diabetic Nephropathy
• Kidney Diseases

Intervention

Drug:
• Addition of furosemide 20 mg oral bid to baseline regimen

Locations

Country	Name	City	State
United States	Kaiser Permanente of Northern California, Santa Clara and San Jose	Santa Clara	California
United States	Stanford University Medical Center	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The amount of protein in the urine after 8 weeks of treatment.
Secondary	The estimated glomerular filtration rate after 8 weeks of treatment.