Aldosterone in Diabetic Nephropathy

Diabetic Nephropathy Clinical Trial

— ALDODN  

Official title:

Effect of Aldosterone Antagonism in the Reduction of Albuminuria and Diastolic Disfunction of Patients With Diabetic Nephropathy.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00870402
• Other study ID #: SA08I20032
• Status: Recruiting
• Phase: Phase 4
• First received: March 25, 2009
• Last updated: March 25, 2009
• Start date: March 2009
• Est. completion date: March 2010

Study information

• Verified date: March 2009
• Source: Universidad Los Andes, Chile
• Contact: Francisco G Espinoza, MD
• Phone: 56 - 2 -91380529
• Email: fespinoz[@]mi.cl
• Is FDA regulated: No
• Health authority: Chile: Comisión Nacional de Investigación Científica y Tecnológica
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether spironolactone are effective in the reduction of albuminuria and diastolic disfunction of subjects with diabetic nephropathy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: March 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

Inclusion Criteria:

• Diabetic subjects with maximum ten years after diagnostic

• Diabetic nephropathy with albuminuria

• Normal renal function

• Diastolic disfunction

• Taking a IECA or ARA drug family previously

Exclusion Criteria:

• Diabetics subjects with macroangiopathy

• Acute coronary syndrome in the three months before

• Hyperkalemia > 5.5 mEq/L

• Pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Nephropathies
• Diabetic Nephropathy
• Kidney Diseases

Intervention

Drug:
• Spironolactone
25 mg per day for 9 months
• Placebo
Placebo 1 tablet per day for nine months

Locations

Country	Name	City	State
Chile	University of Los Andes	Santiago

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Los Andes, Chile

Country where clinical trial is conducted

Chile, 

References & Publications (1)

Kozie DW, Hassul M, Kimm J. Effect of tympanic membrane perforations on air caloric response in monkeys. Trans Sect Otolaryngol Am Acad Ophthalmol Otolaryngol. 1976 Mar-Apr;82(2):203-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of albuminuria		9 months	Yes
Secondary	Reduction of diastolic disfunction		9 months	Yes