Study Comparing the Safety of BG9588 (Anti-CD40L Antibody) Against Standard Treatment in Kidney Transplantation

Summary

The most common problem following a kidney transplant is the development of acute or chronic rejection. Rejection is the immunologic reaction in which the body refuses to accept the transplanted organ. The body's immune system will make destructive antibodies that will attempt to attack the transplanted organ. In order to prevent organ rejection, all patients receiving an allograft (a graft transplanted between genetically non-identical individuals of the same species) must take anti-rejection therapy. These medications function by lowering the body's natural immune system. Often these medications are associated with significant side effects ranging from infections to cancer. This study is designed to test whether the drug presently known as BG9588 (Antova TM) can reduce the incidence of organ rejection following kidney transplants in humans. More specifically, the study will attempt to assess the safety of BG9588 when given alone or when given in combination with other anti-rejection therapies. Safety will be measured by the amount of acute or chronic rejections, and immunological graft losses. Subjects for the study will be made up of non-human primates (monkeys) and humans. Up to 5 subjects in each of the groups receiving kidney transplants will be placed on a 12 month course of BG9588 with or without additional anti-rejection drugs. BG9588 will be given intravenously (injected through a vein) prior to the transplant and then in a decreased dose with a decreased frequency over the year. Following the 12 months of therapy subjects may be eligible for additional monthly therapy. The long-term follow up will occur through 30 months after the last dose of BG9588. Subjects will undergo periodic tests and evaluations throughout the course of the study. These tests will assess the body's immune system and detect the presence of rejection.

Timeline

Start

1999-05

Primary completion

—

Completion

2000-04

Publications

• Background Eggers PW. Effect of transplantation on the Medicare end-stage renal disease program. N Engl J Med. 1988 Jan 28;318(4):223-9. doi: 10.1056/NEJM198801283180406.
• Background Morris PJ. Renal transplantation: a quarter century of achievement. Semin Nephrol. 1997 May;17(3):188-95.
• Background Gaber AO, First MR, Tesi RJ, Gaston RS, Mendez R, Mulloy LL, Light JA, Gaber LW, Squiers E, Taylor RJ, Neylan JF, Steiner RW, Knechtle S, Norman DJ, Shihab F, Basadonna G, Brennan DC, Hodge EE, Kahan BD, Kahan L, Steinberg S, Woodle ES, Chan L, Ham JM, Schroeder TJ, et al. Results of the double-blind, randomized, multicenter, phase III clinical trial of Thymoglobulin versus Atgam in the treatment of acute graft rejection episodes after renal transplantation. Transplantation. 1998 Jul 15;66(1):29-37. doi: 10.1097/00007890-199807150-00005.

Drugs

Indications

No indication recorded.