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

Stopped early · Phase 2

Conditions studied: Kidney Transplantation

In brief

This randomized trial will enroll adult recipients of HLA-identical living kidney transplants who are at least 1 year post-transplant. All subjects will be taking Prograf (tacrolimus) or cyclosporine and mycophenolic acid (CellCept or Myfortic) and then be randomized (1:2) to either continue calcineurin inhibitors or to taper off of calcineurin inhibitors. The hypothesis is that mycophenolic acid monotherapy permits long-term rejection-free renal allograft function in the absence of long-term calcineurin inhibitors in this fully matched renal transplant cohort.

Key facts

Study ID

NCT01053221

Run by

University of Wisconsin, Madison

People needed

16

Starts

2006-03-01

Expected to finish

2012-08-01

Last updated by the study team

2019-07-05

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 investigator),,
• 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 enrollment.

Where it is running

• University of Wisconsin — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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