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

• Status: Terminated
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Wisconsin, Madison
• Treatments: Calcineurin Inhibitors; Cyclosporine; Cyclosporins; Mycophenolate mofetil; Mycophenolic Acid; Tacrolimus

Criteria

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 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.