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Aldosterone in Diabetic Nephropathy (ALDODN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00870402
Recruitment Status : Unknown
Verified March 2009 by Universidad Los Andes, Chile.
Recruitment status was:  Recruiting
First Posted : March 27, 2009
Last Update Posted : March 27, 2009
Information provided by:
Universidad Los Andes, Chile

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 Type : Interventional  (Clinical Trial)
Estimated 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 : March 2009
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. Reduction of albuminuria [ Time Frame: 9 months ]

Secondary Outcome Measures :
  1. Reduction of diastolic disfunction [ Time Frame: 9 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Senior)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00870402

Contact: Francisco G Espinoza, MD 56 - 2 -91380529 ext 000

University of Los Andes Recruiting
Santiago, Chile, 762000
Contact: Helia M Morales, MD    56 - 2 - 93381451 ext 000   
Principal Investigator: Francisco G Espinoza, MD         
Sponsors and Collaborators
Universidad Los Andes, Chile

Responsible Party: Francisco Espinoza Villegas, Departament of Internal Medicine, University of los Andes Identifier: NCT00870402     History of Changes
Other Study ID Numbers: SA08I20032
First Posted: March 27, 2009    Key Record Dates
Last Update Posted: March 27, 2009
Last Verified: March 2009

Keywords provided by Universidad Los Andes, Chile:
diastolic disfunction

Additional relevant MeSH terms:
Kidney Diseases
Diabetic Nephropathies
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Natriuretic Agents