Spironolactone After Liver Transplant

Phase 4

Completed

• Conditions: Transplant, Liver
• Interventions: Drug: Spironolactone

• Registration Number: NCT02883400
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2016-08-25
• Study First Submitted QC: 2016-08-25
• Study First Posted: 2016-08-30
• Primary Completion: 2018-01
• Study Completion: 2018-01
• Results First Submitted: 2019-01-21
• Status Verified: 2021-06
• Results First Submitted QC: 2021-06-28
• Results First Posted: 2021-06-29
• Last Update Submitted: 2022-04-19
• Last Update Posted: 2022-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• liver transplant

Exclusion Criteria

• dual organ transplant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
spironolactone	Spironolactone	spironolactone

Primary Outcome Measures

Name	Time	Method
Glomerular Filtration Rate (GFR)	18 months	The primary analyses were based on the difference between each estimated GFR measure and iothalamate scan.

Trial Locations

Locations (1)

CHS; 🇺🇸 Charlotte, North Carolina, United States