Spironolactone and Prevention of Calcineurin Inhibitor To... | NCT01021943

Studies
Spironolactone and Prevention of Calcineurin Inhibitor Toxicity in Kidney Transplant Recipients

NCT01021943

Sponsor

Instituto Nacional de Cardiologia Ignacio Chavez

Status

Suspended

Last Update Posted

Jul 24, 2014Estimated

Enrollment

40Estimated

Phase

Phase 2

Conditions

Kidney Transplant

Interventions

spironolactone
Placebo

Countries

Mexico

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2014

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2009

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Nov 30, 2009

First Submission Date that Met QC Criteria

Nov 30, 2009

First Posted Date

Dec 1, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 23, 2014

Last Update Posted Date

Jul 24, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Magdalena Madero, Chief Nephrology Division, Instituto Nacional de Cardiologia Ignacio ChavezPrincipal Investigator

Lead Sponsor

Instituto Nacional de Cardiologia Ignacio ChavezOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The main objective of this study is to assess the effect of spironolactone on interstitial fibrosis in kidney transplant recipients receiving calcineurin inhibitors

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Half of the subjects will be assigned to receive either spironolactone or placebo for 6 months	Drug: Placebo
spironolactone	Active Comparator	Half of the subjects will be randomized to receive spironolactone for 6 months	Drug: spironolactone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
spironolactone	Drug	Half of the subjects will be assigned to receive 25 mg of spironolactone for 6 months	spironolactone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Interstitial fibrosis in kidney transplant biopsies (time zero biopsy and at 6 months post intervention)		2 years

Secondary Outcomes

Measure	Description	Time Frame
allograft function and proteinuria		2 years
Fibrosis markers in kidney biopsies such as TGF-B		2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Kidney Failure
Age > 18
Kidney transplant recipients

Exclusion Criteria:

Patients taking angiotensin receptor blockers or inhibitors of the angiotensin reconverting enzyme
Kidney transplant performed more than one month from enrollment in the study
Hyperkalemia (K> 5.5 meqL)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Instituto Nacional Nutricion Salvador Zubiran		México		14080	Mexico

Condition Browse Module

MeSH Terms

ID	Term
D005355	Fibrosis

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013148	Spironolactone

Ancestor Terms

ID	Term
D007783	Lactones
D009930	Organic Chemicals
D011283	Pregnenes
D011278	Pregnanes
D013256

Browse Leaves

Not provided

Browse Branches

Not provided