Aldosterone in Diabetic Nephropathy (ALDODN)

Universidad de los Andes, Chile

Status and phase: Unknown; Phase 4

Conditions: Diabetic Nephropathy

Treatments: Drug: Spironolactone; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00870402

SA08I20032

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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160 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: Spironolactone

2

Placebo Comparator group

Treatment:

Drug: Placebo