Reducing Donor Specific Antibody (DSA) Strength in Maintenance Kidney Transplant Recipients (DSA Study)
Condition: Transplant; Failure, Kidney
MeSH terms: Renal Insufficiency
Intervention: Myfortic Escalation
Intervention description: Dose increases of 180 mg every 3 months until DSA titer is zero or until maximum tolerable dose of EC-MPS is achieved. Maximum dose will not exceed 2160 mg daily.
Intervention MeSH terms: Mycophenolic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Kidney Transplantation; Mycophenolic Acid; Donor-Specific Antibodies; Kidney Rejection

Summary:

      The purpose of this study is to demonstrate that increased dosages of mycophenolic acid in
      maintenance kidney transplant recipients may cause a reduction in donor-specific antibodies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Recipients of cadaveric, living related or living unrelated kidney transplant with
             positive DSA titer.

          -  Males and females, 18-75 years of age.

          -  Patients currently receiving MPA (500mg to 2500 mg of CellCept daily or 360 mg to 1800
             mg of myfortic daily), cyclosporine or tacrolimus with or without corticosteroids as
             part of their immunosuppressive regimen for at least 6 months.

          -  Females of childbearing potential must have a negative pregnancy test prior to
             enrollment. The test should be performed at baseline visit. Effective contraception
             must be used during the trial, and for 4 weeks following discontinuation of the study
             medication.

          -  Patients who are willing and able to participate in the full course of the study and
             from whom written informed consent has been obtained.

        Exclusion criteria:

          -  Multi-solid or cellular organ transplants (e.g. combined with pancreas, liver, islet,
             bone marrow), either concurrent or previous (with exception that a second kidney
             transplant is allowed).

          -  Evidence of graft rejection or treatment of acute rejection within 14 days prior to
             Baseline visit.

          -  Patients who have received any investigational drug within 4 weeks prior to study
             entry.

          -  Patients with thrombocytopenia (<75,000/mm3), with an absolute neutrophil count of
             <1,500/mm3 and/or leukocytopenia (<4,000/mm3), and/or hemoglobin <9.0 g/dL prior to
             enrollment.

          -  The presence of a severe GI disorder (such as Irritable Bowel Syndrome, Inflammatory
             Bowel Disease and known Peptic Ulcer Disease).

          -  Presence of clinically significant infection requiring continued therapy, chronic
             infection (e.g. HIV, Hep B and Hep C), malignancy (within last 5 years, except excised
             squamous or basal cell carcinoma of the skin), lymphoma or renal toxicity that would
             interfere with the appropriate conduct of the study.

          -  Evidence of severe liver disease (incl. abnormal liver profile i.e. AST, ALT or total
             bilirubin ≥ 3 times ULN) or severe diarrhea or active peptic ulcer disease that would
             interfere with the appropriate conduct of the study.

          -  Abnormal physical or laboratory findings of clinical significance within 2 weeks of
             inclusion which would interfere with the objectives of the study.

          -  Patients with symptoms of significant somatic or mental illness or evidence of drug
             and/or alcohol abuse.

          -  Patients receiving > 10 mg/day prednisone dose.

          -  History of hypersensitivity to any of the study drugs or to drugs with similar
             chemical structures to MPA.

          -  Patients not making DSA antibodies.

          -  Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a
             female after conception and until the termination of gestation, confirmed by a
             positive hCG laboratory test (local); females of childbearing potential who are
             unwilling to use effective means of contraception and who are planning to become
             pregnant.

          -  Any other medical condition that, in the opinion of the site investigator based on
             recall or chart review would interfere with completing the study, including but not
             limited to visual problems or cognitive impairment.