Spironolactone After Liver Transplant

NCT ID: NCT02883400

Last Updated: 2022-04-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2018-01-31

Brief Summary

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To study spironolactone to prevent calcineurin inhibitor (CNI) kidney injury.

Detailed Description

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The aim of this study is to determine if spironolactone decreases nephrotoxicity from calcineurin inhibitors in liver transplant recipients and to determine the best study of renal function in liver transplant recipients.

Conditions

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Transplant, Liver

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SOC-Standard of care

standard of care, nontreatment

Group Type NO_INTERVENTION

No interventions assigned to this group

spironolactone

spironolactone

Group Type EXPERIMENTAL

Spironolactone

Intervention Type DRUG

spironolactone 25 mg up to 50 mg

Interventions

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Spironolactone

spironolactone 25 mg up to 50 mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* liver transplant

Exclusion Criteria

* dual organ transplant
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark W. Russo, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Charolinas Healthcare System

Locations

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CHS

Charlotte, North Carolina, United States

Site Status

Countries

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United States

References

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Russo MW, Krista Bossi, Gale Groseclose, Levi DM, Lon Eskind, Bennett Noell, Anderson WE, Zamor PJ, Vincent Casingal. Estimates of Glomerular filtration rate in liver transplant recipients are not accurate: A role for 24 hour urine creatinine clearance. Archives of Transplantation 2018:2:1-5.

Reference Type BACKGROUND

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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12-14-03A

Identifier Type: -

Identifier Source: org_study_id

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