Alemtuzumab (Campath 1H) induction with tacrolimus monotherapy is safe for high immunological risk renal transplantation.

Immunosuppression for immunologically high-risk renal transplant patients usually involves antithymocyte globulin induction with triple drug maintenance therapy. Alemtuzumab, a humanized anti-CD52 antibody, has shown promise in tolerogenic induction protocols, requiring minimal maintenance immunosuppression. In this prospective, open-label, randomized, controlled trial, we enrolled 21 high immunological risk patients (i.e., panel reactive antibody>20% or previous transplant). Patients received either single-dose alemtuzumab given before graft reperfusion, with tacrolimus monotherapy, or four doses of Thymoglobulin with tacrolimus, mycophenolate, and steroids. Median follow-up was 377 days. One patient in the Thymoglobulin group who suffered primary graft nonfunction died. One-year cumulative graft survival was 85.7% for the alemtuzumab group and 87.5% for the Thymoglobulin group. Two alemtuzumab and three Thymoglobulin patients suffered rejection episodes. Infection rates were similar. Early results of this ongoing study indicate that a tolerogenic protocol with alemtuzumab induction and tacrolimus maintenance monotherapy is safe in immunologically high-risk renal transplant patients.

Randomized controlled trial of FTY720 versus MMF in de novo renal transplantation.

BACKGROUND: Phase II trials of FTY720, a novel immunomodulator, have shown promise in preventing rejection with both standard and reduced cyclosporine exposure. This study was designed to confirm those findings. METHODS: This one-year, multicenter, randomized, phase III study in 696 de novo renal transplant patients compared FTY720 5 mg plus reduced-dose cyclosporine (RDC) or FTY720 2.5 mg plus full-dose cyclosporine (FDC) with mycophenolate mofetil (MMF) plus FDC. All patients received concomitant corticosteroid therapy without antibody induction. The primary efficacy composite endpoint was the incidence of first treated biopsy-proven acute rejection (treated BPAR), graft loss, death or premature study discontinuation at month 12. RESULTS: FTY720 2.5 mg plus FDC was demonstrated to be non-inferior to MMF plus FDC as the primary efficacy endpoint (30.8% and 30.6%) was comparable. The FTY720 5 mg plus RDC treatment regimen was discontinued due to an increased incidence of acute rejection episodes (primary endpoint 43.3%). FTY720 was associated with significantly lower creatinine clearance with a mean difference at 12 months between FTY720 2.5 mg plus FDC and MMF plus FDC of 8 ml/min. CONCLUSIONS: While FTY720 2.5 mg plus FDC yielded similar efficacy to MMF plus FDC, the FTY720 5 mg plus RDC did not allow a 50% reduction in cyclosporine exposure. The associated lower creatinine clearance indicated that FTY720 combined with cyclosporine provided no benefit over standard care.

Campath and renal transplant rejection.

No clear guidelines exist for the treatment of acute vascular rejection following renal transplantation. This report documents one patient who was treated with plasmapheresis, immunoglobulin and Campath with good initial response. However, rejection recurred resulting in graft loss and, in addition, the patient developed post-transplant lymphoma.

Renal cortical adenoma incidentally found during living donor nephrectomy.

We report a living related kidney donor incidentally found to have a renal cortical adenoma at nephrectomy. The patient is a 53-year-old man accepted for living related kidney donation. Predonation workup revealed a solitary left renal artery and, on the right kidney, a main artery with a small accessory artery in theupper pole. No other abnormalities were found in the medical history, physical examination, or laboratory and radiological studies. A left laparoscopic nephrectomy was planned. However, during dissection of the upper pole, a 5-mm mass was noted. The nephrectomy was completed, and the organ was preserved in cold University of Wisconsin solution. Permanent section histology showed that the lesion was mostly likely a renal cortical adenoma. As the risk of malignant transformation with immunosuppression could not be adequately determined, the kidney was not transplanted into the recipient. The donor elected not to have the kidney replaced, and the organ was discarded.