Single Center Pilot Study of Corticosteroid Discontinuation in Liver Transplant Recipients

University of Cincinnati

Status and phase: Completed; Phase 4

Conditions: Liver Transplantation

Treatments: Drug: tacrolimus; Drug: mycophenolate mofetil; Drug: Prednisone

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00374231

CSWD Liver

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Immunosuppression

Experimental group

Description:

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.

Treatment:

Drug: Prednisone

Drug: mycophenolate mofetil

Drug: tacrolimus