Single Center Pilot Study of Corticosteroid Discontinuation in Liver Transplant Recipients

Liver Transplantation Clinical Trial

Official title:

A Single Center, Pilot Study of Corticosteroid Discontinuation in Liver Transplant Recipients Utilizing a Tacrolimus/Mycophenolate Mofetil Based Maintenance Immunosuppression Protocol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00374231
• Other study ID #: CSWD Liver
• Status: Completed
• Phase: Phase 4
• First received: September 8, 2006
• Last updated: November 23, 2015
• Start date: October 2002
• Est. completion date: January 2008

Study information

• Verified date: November 2015
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liver Transplantation

Intervention

Drug:
• tacrolimus
Tacrolimus is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis.
• mycophenolate mofetil
Mycophenolate mofetil is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis.
• Prednisone
Prednisone is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis.

Locations

Country	Name	City	State
United States	University of Cincinnati	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University of Cincinnati	Astellas Pharma Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time Post Transplant Corticosteroid Withdrawal	The mean days from post transplant corticosteroid withdrawal.	12 months	No
Primary	Incidence of Biopsy Confirmed Acute Rejection at 12 Months.		12 months	Yes
Secondary	Patient Survival.		12 months	Yes