Rituximab Treatment to Block HLA Antibodies in Renal Transplant Recipients

Inclusion Criteria: * Recipient of a primary cadaver or living donor renal allograft * 18-64 years of age * At least 6 months and no more than 10 years post renal transplant * Serum clearly positive for defined DSA * Renal biopsy positive for C4d staining within 28 days before study Day 1 treatment * Blood positive for Cd 19/20 cells at greater than/equal to 50 % of lower limit of normal * Baseline serum creatinine 1.7-3.0 mg/dl * On stable doses of tacrolimus and MMF for at least 1 month prior to study entry * Able and willing to sign IRB approved consent form and comply with the requirements of the screen, treatment and follow-up phase of the protocol * Negative serum pregnancy test (women of child bearing potential) * Men and women of reproductive potential agree to use an acceptable method of birth control during treatment, for twelve months after treatment completion, or until B cell counts return to normal, whichever is longer Exclusion Criteria: * Hemoglobin: \< 8.5 gm/dL * Platelets: \< 100.00/mm * White blood cell count: \< 3000/mm3 * AST or ALT . 2.5 x Upper Limit of Normal unless related to primary disease * Positive Hepatitis B or C serology * History of positive HIV * Treatment with any investigational agen within 4 weeks of screening or 5 half-lives of the investigational drug (whichever is longer) * Receipt of a live vaccine within 4 weeks prior to study entry * Previous treatment with rituximab (rituxan) * History of severe allergic or anaphylactic reaction…