Aldosterone in Diabetic Nephropathy (ALDODN)

U

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

160 participants in 2 patient groups, including a placebo group

1
Experimental group
Treatment:
Drug: Spironolactone
2
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Central trial contact

Francisco G Espinoza, MD

Data sourced from clinicaltrials.gov

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