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DSR-guided Tacrolimus Withdrawal to Myfortic Monotherapy in Liver Transplantation

18 Years
Not Enrolling
Liver Transplant

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Trial Information

DSR-guided Tacrolimus Withdrawal to Myfortic Monotherapy in Liver Transplantation

The hypothesis to be tested is that donor-microchimerism in specific cell populations
promotes the development of donor-specific regulation which in turn allows for long-term
maintenance therapy with a single drug (Myfortic) in selected patients leading to superior
long-term outcomes. Subjects will be enrolled post-transplantation and will be liver
transplant recipients who meet the eligibility and exclusion criteria. We will use
post-transplant monitoring for donor-specific immunologic regulation (DSR+/ DSA negative) to
direct the withdrawal of patients to Myfortic monotherapy. Donor microchimerism, DSR, DSA
development will be performed on samples obtained every six months from patients on study.
The ultimate objective of the study is to use immunologic monitoring to develop a rational
approach to achieving individualized immunosuppression for liver transplant patients.

Inclusion Criteria:

- Male or female subjects, ages 18 years and older who have received a primary liver
transplant from a deceased donor for 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.

Exclusion Criteria:

- 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 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 OKT3 at anytime

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

MDRD estimation of GFR.

Outcome Time Frame:

24 months post randomization/enrollment

Safety Issue:


Principal Investigator

Will Burlingham, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Wisconsin, Madison


United States: Food and Drug Administration

Study ID:

UW- H2010-0121



Start Date:

November 2011

Completion Date:

June 2012

Related Keywords:

  • Liver Transplant
  • immunosuppression
  • anti-rejection
  • immune tolerance



University of Wisconsin- Madison Madison, Wisconsin  53792