ALDODN: Aldosterone in Diabetic Nephropathy

• Sponsor: Universidad de los Andes, Chile (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00870402
• Collaborator: (none)
• Enrollment: 160
• Location: 1
• Arms: 2
• Duration (Months): 12
• Patients Per Site Per Month: 13.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Nephropathy	Drug: Spironolactone; Drug: Placebo	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 160 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Effect of Aldosterone Antagonism in the Reduction of Albuminuria and Diastolic Disfunction of Patients With Diabetic Nephropathy.
• Study Start Date: Mar 1, 2009
• Anticipated Primary Completion Date: Dec 1, 2009
• Anticipated Study Completion Date: Mar 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: Spironolactone; 25 mg per day for 9 months
Placebo Comparator: 2	Drug: Placebo; Placebo 1 tablet per day for nine months

Outcome Measures

Primary Outcome Measures

1. Reduction of albuminuria [9 months]

Secondary Outcome Measures

1. Reduction of diastolic disfunction [9 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Los Andes	Santiago		Chile	762000

Sponsors and Collaborators

• Universidad de los Andes, Chile

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• ClinicalTrials.gov Identifier: NCT00870402
• Other Study ID Numbers: SA08I20032
• First Posted: Mar 27, 2009
• Last Update Posted: Mar 27, 2009
• Last Verified: Mar 1, 2009

• Keywords provided by , ,: aldosterone; albuminuria; diastolic disfunction; hyperkalemia
• Additional relevant MeSH terms: Kidney Diseases; Diabetic Nephropathies; Spironolactone

Study Results

No Results Posted as of Mar 27, 2009