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Aldosterone in Diabetic Nephropathy (ALDODN)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2009 by Universidad Los Andes, Chile.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00870402
First Posted: March 27, 2009
Last Update Posted: March 27, 2009
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.
Information provided by:
Universidad Los Andes, Chile
  Purpose
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 Intervention Phase
Diabetic Nephropathy Drug: Spironolactone Drug: Placebo Phase 4

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Universidad Los Andes, Chile:

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

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

Estimated Enrollment: 160
Study Start Date: March 2009
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Spironolactone
25 mg per day for 9 months
Placebo Comparator: 2 Drug: Placebo
Placebo 1 tablet per day for nine months

  Eligibility

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
Criteria

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
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 ClinicalTrials.gov identifier (NCT number): NCT00870402


Contacts
Contact: Francisco G Espinoza, MD 56 - 2 -91380529 ext 000 fespinoz@mi.cl

Locations
Chile
University of Los Andes Recruiting
Santiago, Chile, 762000
Contact: Helia M Morales, MD    56 - 2 - 93381451 ext 000    heliamorales@gmail.com   
Principal Investigator: Francisco G Espinoza, MD         
Sponsors and Collaborators
Universidad Los Andes, Chile
  More Information

Publications:
Responsible Party: Francisco Espinoza Villegas, Departament of Internal Medicine, University of los Andes
ClinicalTrials.gov Identifier: NCT00870402     History of Changes
Other Study ID Numbers: SA08I20032
First Submitted: March 25, 2009
First Posted: March 27, 2009
Last Update Posted: March 27, 2009
Last Verified: March 2009

Keywords provided by Universidad Los Andes, Chile:
aldosterone
albuminuria
diastolic disfunction
hyperkalemia

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