Aldosterone in Diabetic Nephropathy

NCT ID: NCT00870402

Last Updated: 2009-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2010-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetic Nephropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

Group Type EXPERIMENTAL

Spironolactone

Intervention Type DRUG

25 mg per day for 9 months

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo 1 tablet per day for nine months

Interventions

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Spironolactone

25 mg per day for 9 months

Intervention Type DRUG

Placebo

Placebo 1 tablet per day for nine months

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad de los Andes, Chile

OTHER

Sponsor Role lead

Responsible Party

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Departament of Internal Medicine, University of los Andes

Locations

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University of Los Andes

Santiago, Santiago Metropolitan, Chile

Site Status RECRUITING

Countries

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Chile

Central Contacts

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Francisco G Espinoza, MD

Role: CONTACT

56 - 2 -91380529 ext. 000

Facility Contacts

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Helia M Morales, MD

Role: primary

56 - 2 - 93381451 ext. 000

References

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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.

Reference Type BACKGROUND
PMID: 820032 (View on PubMed)

Chung EY, Ruospo M, Natale P, Bolignano D, Navaneethan SD, Palmer SC, Strippoli GF. Aldosterone antagonists in addition to renin angiotensin system antagonists for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev. 2020 Oct 27;10(10):CD007004. doi: 10.1002/14651858.CD007004.pub4.

Reference Type DERIVED
PMID: 33107592 (View on PubMed)

Other Identifiers

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SA08I20032

Identifier Type: -

Identifier Source: org_study_id

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