Spironolactone in Diabetic Nephropathy

Diabetic Nephropathy Clinical Trial

Official title:

Spironolactone in Diabetic Nephropathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00317954
• Other study ID #: 2612-2233
• Status: Completed
• Phase: Phase 4
• First received: April 21, 2006
• Last updated: April 21, 2006
• Start date: September 2003
• Est. completion date: July 2005

Study information

• Verified date: August 2005
• Source: Steno Diabetes Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics CommitteeDenmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Nephropathies
• Diabetic Nephropathy
• Kidney Diseases

Intervention

Drug:
• Spironolactone

Locations

Country	Name	City	State
Denmark	Steno Diabetes Center	Gentofte

Sponsors (1)

Lead Sponsor	Collaborator
Steno Diabetes Center

Country where clinical trial is conducted

Denmark, 

References & Publications (2)

Rossing K, Schjoedt KJ, Smidt UM, Boomsma F, Parving HH. Beneficial effects of adding spironolactone to recommended antihypertensive treatment in diabetic nephropathy: a randomized, double-masked, cross-over study. Diabetes Care. 2005 Sep;28(9):2106-12. — View Citation

Schjoedt KJ, Rossing K, Juhl TR, Boomsma F, Rossing P, Tarnow L, Parving HH. Beneficial impact of spironolactone in diabetic nephropathy. Kidney Int. 2005 Dec;68(6):2829-36. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in albuminuria
Primary	Changes in blood pressure
Secondary	Changes in glomerular filtration rate