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Spironolactone for Reducing Proteinuria in Diabetic Nephropathy

This study has been completed.
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00498537
First received: July 6, 2007
Last updated: October 16, 2008
Last verified: May 2008
History of Changes
  Purpose

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 Intervention
Diabetic Nephropathy
 Drug: spironolactone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Spironolactone for Reducing Proteinuria in Diabetic Nephropathy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • reduction in proteinuria [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in GFR and incidence of hyperkalemia [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: January 2003
Study Completion Date: June 2006
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1 Drug: spironolactone
2 Drug: spironolactone

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

The study is completed. Inclusion criteria was diabetic nephropathy

Exclusion Criteria:

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00498537

Locations
United States, Ohio
VA Medical Center, Dayton
Dayton, Ohio, United States, 45428
Sponsors and Collaborators
Department of Veterans Affairs
Investigators
Principal Investigator: Mohammad G. Saklayen, MD VA Medical Center, Dayton
  More Information

Publications:

Responsible Party: Saklayen, Mohammad - Principal Investigator, Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00498537     History of Changes
Other Study ID Numbers: 0024
Study First Received: July 6, 2007
Last Updated: October 16, 2008
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
spironolactone
aldosterone
diabetic nephropathy
proteinuria
 hyperkalemia
albuminuria
renal failure

Additional relevant MeSH terms:
Diabetic Nephropathies
Kidney Diseases
Proteinuria
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Urination Disorders
Urological Manifestations
Signs and Symptoms
 Spironolactone
Aldosterone Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Diuretics
Natriuretic Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013