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Aldosterone in Diabetic Nephropathy (ALDODN)

Primary Purpose

Diabetic Nephropathy

Status
Unknown status
Phase
Phase 4
Locations
Chile
Study Type
Interventional
Intervention
Spironolactone
Placebo
Sponsored by
Universidad de los Andes, Chile
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Nephropathy focused on measuring aldosterone, albuminuria, diastolic disfunction, hyperkalemia

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Los AndesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Reduction of albuminuria

Secondary Outcome Measures

Reduction of diastolic disfunction

Full Information

First Posted
March 25, 2009
Last Updated
March 25, 2009
Sponsor
Universidad de los Andes, Chile
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1. Study Identification

Unique Protocol Identification Number
NCT00870402
Brief Title
Aldosterone in Diabetic Nephropathy
Acronym
ALDODN
Official Title
Effect of Aldosterone Antagonism in the Reduction of Albuminuria and Diastolic Disfunction of Patients With Diabetic Nephropathy.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Unknown status
Study Start Date
March 2009 (undefined)
Primary Completion Date
December 2009 (Anticipated)
Study Completion Date
March 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Universidad de los Andes, Chile

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Nephropathy
Keywords
aldosterone, albuminuria, diastolic disfunction, hyperkalemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Spironolactone
Intervention Description
25 mg per day for 9 months
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo 1 tablet per day for nine months
Primary Outcome Measure Information:
Title
Reduction of albuminuria
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Reduction of diastolic disfunction
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Francisco G Espinoza, MD
Phone
56 - 2 -91380529
Ext
000
Email
fespinoz@mi.cl
Facility Information:
Facility Name
University of Los Andes
City
Santiago
ZIP/Postal Code
762000
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helia M Morales, MD
Phone
56 - 2 - 93381451
Ext
000
Email
heliamorales@gmail.com
First Name & Middle Initial & Last Name & Degree
Francisco G Espinoza, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
820032
Citation
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.
Results Reference
background
PubMed Identifier
33107592
Citation
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.
Results Reference
derived

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Aldosterone in Diabetic Nephropathy

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