Spironolactone for Reducing Proteinuria in Diabetic Nephropathy - Full Text View

Sponsored by:	Department of Veterans Affairs
Information provided by:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00498537

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:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	Spironolactone for Reducing Proteinuria in Diabetic Nephropathy

Resource links provided by NLM:

MedlinePlus related topics: Diabetic Kidney Problems Urine and Urination

Drug Information available for: Spironolactone

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:

Saklayen MG, Gyebi LK, Tasosa J, Yap J. Effects of Additive Therapy With Spironolactone on Proteinuria in Diabetic Patients Already on ACE Inhibitor or ARB Therapy: Results of a Randomized, Placebo-Controlled, Double-Blind, Crossover Trial. J Investig Med. 2008 Apr;56(4):714-9.

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

Keywords provided by Department of Veterans Affairs:

spironolactone
aldosterone
diabetic nephropathy
proteinuria

hyperkalemia
albuminuria
renal failure

Study placed in the following topic categories:

Diabetic Nephropathies
Albuminuria
Urination Disorders
Hormone Antagonists
Diuretics
Hormones, Hormone Substitutes, and Hormone Antagonists
Diabetes Mellitus
Hyperkalemia
Endocrine System Diseases
Cardiovascular Agents

Hormones
Spironolactone
Signs and Symptoms
Proteinuria
Aldosterone Antagonists
Urologic Diseases
Kidney Diseases
Endocrinopathy
Diabetes Complications
Kidney Failure

Additional relevant MeSH terms:

Diabetic Nephropathies
Urination Disorders
Hormone Antagonists
Physiological Effects of Drugs
Diuretics
Hormones, Hormone Substitutes, and Hormone Antagonists
Diabetes Mellitus
Endocrine System Diseases
Cardiovascular Agents
Pharmacologic Actions

Spironolactone
Urological Manifestations
Signs and Symptoms
Proteinuria
Aldosterone Antagonists
Urologic Diseases
Natriuretic Agents
Therapeutic Uses
Kidney Diseases
Diabetes Complications

ClinicalTrials.gov processed this record on July 02, 2009