Single Center Pilot Study of Corticosteroid Discontinuation in Liver Transplant Recipients

Phase 4

Completed

• Conditions: Liver Transplantation
• Interventions: Drug: tacrolimus; Drug: mycophenolate mofetil; Drug: Prednisone

• Registration Number: NCT00374231
• Lead Sponsor: University of Cincinnati

Brief Summary

To determine the safety and efficacy of early corticosteroid discontinuation in liver transplant recipients more than 90 days post transplant, utilizing a combination of two drugs (tacrolimus and mycophenolate mofetil) for maintenance immunosuppressant therapy.

Detailed Description

To determine the safety and efficacy of early corticosteroid discontinuation in liver transplant recipients more than 90 days post transplant, utilizing a combination of two drugs (tacrolimus and mycophenolate mofetil) for maintenance immunosuppression therapy.

Study Timeline

• Study Start: 2002-10
• Study First Submitted: 2006-09-08
• Study First Submitted QC: 2006-09-08
• Study First Posted: 2006-09-11
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Results First Submitted: 2013-12-19
• Status Verified: 2015-11
• Results First Submitted QC: 2015-11-23
• Last Update Submitted: 2015-11-23
• Results First Posted: 2015-12-29
• Last Update Posted: 2015-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Greater than 90 days post transplant.
• Free from rejection within the last 30 days.
• Patient with primary diagnosis of AIH will be evaluated on an individual basis.
• Negative pregnancy test.
• Practicing an acceptable method of birth control.
• Capable of providing written informed consent.

Exclusion Criteria

• Rejection within the last 30 days.
• Patients with AIH unable to discontinue corticosteroids.
• Patients currently receiving systemic corticosteroids for other medical diseases in which the physician feels discontinuation is contraindicated.
• Known sensitivity or contraindication to tacrolimus or MMF.
• Kidney, pancreas, islet, heart, lung, or small bowel transplant recipient.
• Pregnant or lactating.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Immunosuppression	Prednisone	All the patients who enroll in this study will receive the same medications (tacrolimus, mycophenolate mofetil, and a short course of steroids) to prevent rejection of the liver transplant. All participants will be gradually taken off prednisone if they are 90 days or longer post liver transplant and have not had a rejection in the last 30 days.
Immunosuppression	tacrolimus	All the patients who enroll in this study will receive the same medications (tacrolimus, mycophenolate mofetil, and a short course of steroids) to prevent rejection of the liver transplant. All participants will be gradually taken off prednisone if they are 90 days or longer post liver transplant and have not had a rejection in the last 30 days.
Immunosuppression	mycophenolate mofetil	All the patients who enroll in this study will receive the same medications (tacrolimus, mycophenolate mofetil, and a short course of steroids) to prevent rejection of the liver transplant. All participants will be gradually taken off prednisone if they are 90 days or longer post liver transplant and have not had a rejection in the last 30 days.

Primary Outcome Measures

Name	Time	Method
Incidence of Biopsy Confirmed Acute Rejection at 12 Months.	12 months

Secondary Outcome Measures

Name	Time	Method
Patient Survival.	12 months

Trial Locations

Locations (1)

University of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States