Clinical trial NCT01053221: Mycophenolic Acid Monotherapy in Recipients of HLA-identical Living-Related Transplantation
Official title: Mycophenolic Acid Monotherapy in Recipients of HLA-identical Living-Related Transplantation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Kidney Transplantation
Keywords: mycophenolate
living donor
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2010-01-21
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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 withdrawal.

Eligibility 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.

Primary outcomes:
measure: Incidence of Kidney Allograft Rejection and Graft Loss
timeFrame: 36 months
Secondary outcomes:
measure: Renal Function Measured by Serum Creatinine and eGFR
timeFrame: 36 months
measure: Number of Incidences of Infection and Malignancy
timeFrame: 36 months
measure: Patient Survival
timeFrame: 36 months
measure: Trans-vivo Delayed Type Hypersensitivity (DTH) Assay
timeFrame: 36 months
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: William Burlingham, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Wisconsin, Madison
name: Hans Sollinger, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: