Spironolactone in Diabetic Nephropathy

Phase 4

Completed

• Conditions: Diabetic Nephropathy

• Registration Number: NCT00317954
• Lead Sponsor: Steno Diabetes Center Copenhagen

Brief Summary

The aim of the study was to evaluate the renoprotective effect (i.e. albuminuria- and bloodpressure lowering effect) of spironolactone 25 mg o.d. in type 1 and type 2 diabetic patients with albuminuria despite recommended antihypertensive treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-09
• Study Completion: 2005-07
• Status Verified: 2005-08
• Study First Submitted: 2006-04-21
• Study First Submitted QC: 2006-04-21
• Last Update Submitted: 2006-04-21
• Study First Posted: 2006-04-25
• Last Update Posted: 2006-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• Diabetes Mellitus
• Diabetic Nephropathy
• Glomerular filtration rate > 30 ml/min/1.73 m2
• Blood pressure > 130/80 mm Hg

Exclusion Criteria

• Child bearing potential
• Plasma-potassium >4.5 mmol/l
• Breastfeeding
• Abuse of alcohol or drugs
• Non-diabetic kidney disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Changes in albuminuria
Changes in blood pressure

Secondary Outcome Measures

Name	Time	Method
Changes in glomerular filtration rate

Trial Locations

Locations (1)

Steno Diabetes Center; 🇩🇰 Gentofte, Denmark