Mycophenolic Acid (MPA) Monotherapy in Liver Transplantation

Stopped early · Not applicable

Conditions studied: Liver Transplant

In brief

To determine whether long-term maintenance therapy with a single drug (Myfortic) applied using advanced immunologic monitoring tools in selected patients can lead to superior native kidney function at 2 years without resulting in increased acute rejection episodes or deterioration of liver allograft function.

Key facts

Study ID

NCT01230502

Run by

University of Wisconsin, Madison

People needed

11

Starts

2011-11-01

Expected to finish

2012-06-01

Last updated by the study team

2014-05-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female subjects, ages 18 years and older who have received a primary liver transplant from a deceased donor for end stage liver disease *(ESLD).
• Women of child-bearing potential must have a negative serum pregnancy test at the time of screening and agree to use a medically acceptable method of contraception throughout the study and for 3 months following discontinuation of study treatment.

You may not qualify if…

• Recipients of multi-organ transplants.
• Recipients with positive crossmatch with their donor (current or previously).
• Subjects with a screening white blood cell count ≤ 2,000 mm3 or absolute neutrophil count (ANC) ≤ 1000, platelet count ≤ 100,000 mm3.
• Recipients with a hematocrit < 32.
• History of malignancy within 5 years of enrollment (except for adequately treated basal cell or squamous cell carcinoma of the skin).
• Subjects who are positive for hepatitis C, hepatitis B surface antigen, or HIV.
• Subjects with previous intolerance to full dose MPA agent.
• Subjects with a history of acute rejection within 6 months prior to study enrollment.
• Subjects who have had chronic ductopenic rejection.
• Subjects who had rejection in the first-year post-transplant and are less than 3 years post-transplant.
• Subjects who had rejection requiring treatment with thymoglobulin or Orthoclone-OKT3 (OKT3) at anytime post-transplant.
• Original cause of ESLD related to autoimmune diseases such as autoimmune hepatitis, primary biliary cirrhosis, and primary sclerosing cholangitis.
• Subjects who have received an investigational drug within 4 weeks of study entry.
• Subjects with a history of a psychological illness or condition such as to interfere with the subject's ability to understand the requirements of the study.
• Female subjects who are pregnant or nursing or females who are unwilling to use contraception during the study.
• Subjects who are currently receiving any therapy for immunosuppression other than a MPA agent and tacrolimus.
• Subjects with a history of hepatocellular carcinoma (T2 >).
• Subjects with severe coexisting disease or presenting with any unstable medical condition which could affect study objectives.
• Subjects who have a known hypersensitivity to tacrolimus or mycophenolate

Where it is running

• University of Wisconsin- Madison — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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