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

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.
 
ClinicalTrials.gov Identifier: NCT00240019
Recruitment Status : Completed
First Posted : October 17, 2005
Last Update Posted : October 17, 2006
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by:
Stanford University

Tracking Information
First Submitted Date  ICMJE October 13, 2005
First Posted Date  ICMJE October 17, 2005
Last Update Posted Date October 17, 2006
Study Start Date  ICMJE December 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: October 13, 2005)
The amount of protein in the urine after 8 weeks of treatment.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 13, 2005)
The estimated glomerular filtration rate after 8 weeks of treatment.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Maximizing the Benefit of Renin-Angiotensin Blocking Drugs in Diabetic Renal Disease.
Official Title  ICMJE Maximizing the Benefit of RAS Blockade in Diabetic Nephropathy
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Diabetic Nephropathy
Intervention  ICMJE Drug: Addition of furosemide 20 mg oral bid to baseline regimen
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: October 13, 2005)
30
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE April 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00240019
Other Study ID Numbers  ICMJE R01-063011
R01DK063011 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE National Institutes of Health (NIH)
Investigators  ICMJE
Principal Investigator: Timothy W Meyer, MD Stanford University
PRS Account Stanford University
Verification Date June 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP