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Spironolactone for Reducing Proteinuria in Diabetic Nephropathy

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. Identifier: NCT00498537
Recruitment Status : Completed
First Posted : July 10, 2007
Last Update Posted : October 17, 2008
Information provided by:
VA Office of Research and Development

Brief Summary:

Introduction: Aldosterone seems to have deleterious effects on the kidneys. Many animal studies and few clinical trials now have shown that suppression of aldosterone by aldosterone receptor blockers ameliorated these effects.

Method: In a double-blind, cross over study, 24 patients with diabetic nephropathy who were already receiving either ACE inhibitor(lisinopril 20-40 mg/day ) or ARB( losartan 25-100 mg/day )were given spironolactone( 25 mg during the first month and 50 mg during the second and third month if serum K remained ok) or matching placebo with 1 month of washout in between. All patients were from a single center and exclusively male veterans. Blood pressure, serum creatinine, serum K and spot urine protein/creatinine were measured at the beginning and end of each study period. The study was started in May of 2003 and completed in May 2006.

Condition or disease Intervention/treatment Phase
Diabetic Nephropathy Drug: spironolactone Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Spironolactone for Reducing Proteinuria in Diabetic Nephropathy
Study Start Date : January 2003
Actual Primary Completion Date : December 2005
Actual Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
1 Drug: spironolactone
2 Drug: spironolactone

Primary Outcome Measures :
  1. reduction in proteinuria

Secondary Outcome Measures :
  1. Changes in GFR and incidence of hyperkalemia

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

The study is completed. Inclusion criteria was diabetic nephropathy

Exclusion Criteria:

Scr >2 mg/dl and serum K > 5meq/L

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00498537

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United States, Ohio
VA Medical Center, Dayton
Dayton, Ohio, United States, 45428
Sponsors and Collaborators
US Department of Veterans Affairs
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Principal Investigator: Mohammad G. Saklayen, MD VA Medical Center, Dayton
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Saklayen, Mohammad - Principal Investigator, Department of Veterans Affairs Identifier: NCT00498537    
Other Study ID Numbers: 0024
First Posted: July 10, 2007    Key Record Dates
Last Update Posted: October 17, 2008
Last Verified: May 2008
Keywords provided by VA Office of Research and Development:
diabetic nephropathy
renal failure
Additional relevant MeSH terms:
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Kidney Diseases
Diabetic Nephropathies
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Urination Disorders
Urological Manifestations
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Natriuretic Agents