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Aldosterone in Diabetic Nephropathy (ALDODN)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Universidad Los Andes.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Universidad Los Andes
ClinicalTrials.gov Identifier:
NCT00870402
First received: March 25, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

Further study details as provided by Universidad Los Andes:

Primary Outcome Measures:
  • Reduction of albuminuria [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Reduction of diastolic disfunction [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
  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
Study First Received: March 25, 2009
Last Updated: March 25, 2009
Health Authority: Chile: Comisión Nacional de Investigación Científica y Tecnológica

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

Additional relevant MeSH terms:
Diabetic Nephropathies
Kidney Diseases
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Spironolactone
Aldosterone Antagonists
 Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Diuretics
Natriuretic Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013