Spironolactone for Reducing Proteinuria in Diabetic Nephropathy

NCT00498537 | Completed

• 1 other identifier: 0024
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Nephropathy

Keywords

spironolactone; aldosterone; diabetic nephropathy; proteinuria; hyperkalemia; albuminuria; renal failure

Outcome Measures

Primary Outcomes (1)

• reduction in proteinuria

Secondary Outcomes (1)

• Changes in GFR and incidence of hyperkalemia

Study Arms (2)

1

OTHER

Drug: spironolactone

2

OTHER

Drug: spironolactone

Interventions

spironolactone DRUG

1; 2

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Scr \>2 mg/dl and serum K \> 5meq/L

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

VA Medical Center, Dayton

Dayton, Ohio, 45428, United States

Location

Related Publications (2)

• 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. doi: 10.2310/JIM.0b013e31816d78e9.

  PMID: 18382267 RESULT

• Chung EY, Ruospo M, Natale P, Bolignano D, Navaneethan SD, Palmer SC, Strippoli GF. Aldosterone antagonists in addition to renin angiotensin system antagonists for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev. 2020 Oct 27;10(10):CD007004. doi: 10.1002/14651858.CD007004.pub4.

  PMID: 33107592 DERIVED

MeSH Terms

Conditions

Diabetic Nephropathies; Proteinuria; Hyperkalemia; Albuminuria; Renal Insufficiency

Interventions

Spironolactone

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Urination Disorders; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Mohammad G. Saklayen, MD

  VA Medical Center, Dayton

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: FED

Study Record Dates

• First Submitted: July 6, 2007
• First Posted: July 10, 2007
• Study Start: January 1, 2003
• Primary Completion: December 1, 2005
• Study Completion: June 1, 2006
• Last Updated: October 17, 2008

Record last verified: 2008-05

Locations

US (1)