Aldosterone in Diabetic Nephropathy - Full Text View

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

First Received on March 25, 2009. No Changes Posted

Sponsor:	Universidad Los Andes
Information provided by:	Universidad Los Andes
ClinicalTrials.gov Identifier:	NCT00870402

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 IV

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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetic Kidney Problems

Drug Information available for: Spironolactone Aldosterone

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:

Kozie DW, Hassul M, Kimm J. Effect of tympanic membrane perforations on air caloric response in monkeys. Trans Sect Otolaryngol Am Acad Ophthalmol Otolaryngol. 1976 Mar-Apr;82(2):203-9. No abstract available.

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 February 09, 2012