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Mycophenolic Acid Monotherapy in Recipients of HLA-identical Living-Related Transplantation

18 Years
75 Years
Open (Enrolling)
Kidney Transplantation

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Trial Information

Mycophenolic Acid Monotherapy in Recipients of HLA-identical Living-Related Transplantation

The objective of the study is to safely move HLA-identical renal transplant recipients from
2 immunosuppressive drugs (calcineurin inhibitor and mycophenolic acid) to mycophenolic acid
monotherapy. Safety will be assessed by monitoring renal function in subjects in the
withdrawal group compared to those who remain on the standard 2-drug immunosuppression
protocol. Results of immunological monitors such as DTH regulation in response to donor
minor antigens and development of anti-donor antibodies will be correlated with successful

Inclusion Criteria:

- Male or female subjects 18-75 years of age.

- Subjects who are recipients of HLA-identical living donor renal allografts from a
sibling and are at least 1 year post transplant, their donors and mothers.

- Subjects must be capable of understanding the purpose and risks of the study and must
sign a statement of informed consent.

Exclusion Criteria:

- GFR <40ml/min;

- diagnosis of SLE,

- Subjects with proteinuria (defined as a protein:creatinine ratio of >1 or an amount
less than this deemed significant on an individual subject basis by the principal

- multi-organ transplant;

- known hypersensitivity to, Prograf, Neoral, CellCept or Myfortic;

- history of documented post transplant non-compliance with medications, transplant
clinic or laboratory follow-up;

- therapy with an investigational immunosuppressive drug within 6 weeks of study entry;

- history of a psychological illness or condition such as to interfere with the
patient's ability to understand the requirements of the study;

- patients on less than 500 mg PO BID of CellCept or 360 mg PO BID of Myfortic at the
time of potential randomization,

- history of humoral rejection post transplant,

- maintenance or for cause treatment with steroids (prednisone) within 3 months of

Type of Study:


Study Design:

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

Outcome Measure:

Incidence of kidney allograft rejection and graft loss

Outcome Time Frame:

36 months

Safety Issue:


Principal Investigator

William Burlingham, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Wisconsin, Madison


United States: Institutional Review Board

Study ID:




Start Date:

March 2006

Completion Date:

June 2013

Related Keywords:

  • Kidney Transplantation
  • mycophenolate
  • living donor



University of WisconsinMadison,, Wisconsin  53792-5666