Spironolactone for Reducing Proteinuria in Diabetic Nephropathy

Completed · Not applicable

Conditions studied: Diabetic Nephropathy

In brief

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.

Key facts

Study ID

NCT00498537

Run by

US Department of Veterans Affairs

People needed

30

Starts

2003-01-01

Expected to finish

2006-06-01

Last updated by the study team

2008-10-17

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The study is completed. Inclusion criteria was diabetic nephropathy

You may not qualify if…

• Scr >2 mg/dl and serum K > 5meq/L

Where it is running

• VA Medical Center, Dayton — Dayton, Ohio, United States

Full record on ClinicalTrials.gov

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