NCT00870402

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2009

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

March 25, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 27, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

March 27, 2009

Status Verified

March 1, 2009

Enrollment Period

9 months

First QC Date

March 25, 2009

Last Update Submit

March 25, 2009

Conditions

Diabetic Nephropathy

Keywords

aldosteronealbuminuriadiastolic disfunctionhyperkalemia

Outcome Measures

Primary Outcomes (1)

  • Reduction of albuminuria

    9 months

Secondary Outcomes (1)

  • Reduction of diastolic disfunction

    9 months

Study Arms (2)

1

EXPERIMENTAL
Drug: Spironolactone

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

SpironolactoneDRUG

25 mg per day for 9 months

1
PlaceboDRUG

Placebo 1 tablet per day for nine months

2

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Diabetics subjects with macroangiopathy
  • Acute coronary syndrome in the three months before
  • Hyperkalemia \> 5.5 mEq/L
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Los Andes

Santiago, Santiago Metropolitan, 762000, Chile

RECRUITING

Related Publications (2)

  • 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.

    PMID: 820032BACKGROUND

  • 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.

    PMID: 33107592DERIVED

MeSH Terms

Conditions

Diabetic NephropathiesAlbuminuriaHyperkalemia

Interventions

Spironolactone

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesProteinuriaUrination DisordersUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsWater-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

LactonesOrganic ChemicalsPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Central Study Contacts

Francisco G Espinoza, MD

CONTACT

56 - 2 -91380529fespinoz@mi.cl

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 25, 2009

First Posted

March 27, 2009

Study Start

March 1, 2009

Primary Completion

December 1, 2009

Study Completion

March 1, 2010

Last Updated

March 27, 2009

Record last verified: 2009-03

Locations

CL(1)