Back to resultsMaximizing the Benefit of Renin-Angiotensin Blocking Drugs in Diabetic Renal Disease.
Primary Purpose
Diabetic Nephropathy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Addition of furosemide 20 mg oral bid to baseline regimen
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Nephropathy
Eligibility 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
Sites / Locations
- Kaiser Permanente of Northern California, Santa Clara and San Jose
- Stanford University Medical Center
Outcomes
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.
Full Information
NCT ID
NCT00240019
First Posted
October 13, 2005
Last Updated
October 16, 2006
Sponsor
Stanford University
Collaborators
National Institutes of Health (NIH)
1. Study Identification
Unique Protocol Identification Number
NCT00240019
Brief Title
Maximizing the Benefit of Renin-Angiotensin Blocking Drugs in Diabetic Renal Disease.
Official Title
Maximizing the Benefit of RAS Blockade in Diabetic Nephropathy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2006
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Stanford University
Collaborators
National Institutes of Health (NIH)
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Nephropathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
30 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Addition of furosemide 20 mg oral bid to baseline regimen
Primary Outcome Measure Information:
Title
The amount of protein in the urine after 8 weeks of treatment.
Secondary Outcome Measure Information:
Title
The estimated glomerular filtration rate after 8 weeks of treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy W Meyer, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser Permanente of Northern California, Santa Clara and San Jose
City
Santa Clara
State/Province
California
ZIP/Postal Code
95051
Country
United States
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Maximizing the Benefit of Renin-Angiotensin Blocking Drugs in Diabetic Renal Disease.
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