Spironolactone in Diabetic Nephropathy

Steno Diabetes Centers

Status and phase: Completed; Phase 4

Conditions: Diabetic Nephropathy

Treatments: Drug: Spironolactone

Study type: Interventional

Funder types: Other

Identifiers

NCT00317954

2612-2233

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind