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Living Donor Kidney Transplants Using Alemtuzumab Pre-Conditioning and Tacrolimus Monotherapy: Long-Term Safety and Efficacy
Date:5/31/2009

ents (77.0%) were weaned to every-other-day or less dosing of tacrolimus monotherapy. Among 60 recipients with ACR, the incidence of pre-weaning ACR was 8.5% and post-weaning ACR was 27.9%. At this time, >/= 90% of recipients remain steroid-free on tacrolimus monotherapy.

In a similar study report, Dr. Tan and colleagues performed 478 consecutive unselected living donor kidney transplants using alemtuzumab pre-conditioning and tacrolimus monotherapy. Once again, they used a series of clinical tests including ELISA antibody titers, donor-specific antibodies and the ImmuKnow assay beginning 6 months posttransplant and at 2-6 months intervals. Using these data, tacrolimus was weaned whenever possible. These patients were followed for an average of 35.6 (+/-19.7) months.

Recipient survivals at 1, 2, 3, and 4 years were 98.4%, 95.3%, 93.3%, and 90.4%, respectively. Graft survivals at the same time points were 97.1%, 89.6%, 85.2%, and 77.5%, respectively. The mean (+/-SD) creatinine (mg/dL) after 1, 2 and 3 years were 1.42 (+/-0.61), 1.56 (+/-0.96) and 1.53 (+/-0.83), respectively. The mean (+/-SD) GFR (mL/min/1.73m(2)) at these time points were 59.2 (+/-23.6), 55.0 (+/-21.7) and 53.9 (+/-21.7), respectively. The cumulative incidence of ACR after 1, 3, 6, 12, 18, 24, 30, and 36 months were 1.9%, 3.1%, 4.2%, 9.2%, 14.0%, 16.3%, 18.8% and 19.5%, respectively.

Weaning to every-other-day or less dosing of tacrolimus monotherapy was attempted in 41% of patients. Among 397 patients with functional grafts, 82 (20.6%) are on spaced-dose tacrolimus monotherapy. A total of 114 recipients had ACR. The incidence of pre-weaning ACR was 11.7% and post-weaning was 30.1%. At this time, >/= 80.6% of recipients remain steroid-free on tacrolimus monotherapy.

The use of the ImmuKnow assay as described in these studies has not been cleared by the U.S. Food & Drug Administration.

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SOURCE Cylex, Inc.
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