Kidney Transplantation Clinical Trial
Official title:
A Multicenter, Open-Label, Study to Determine the Safety of BG9588 (Anti-CD40L Antibody) Therapy Compared to Standard Treatment in Renal Allograft Transplantation
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | April 2000 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Must be a candidate for a renal transplant from a living related, living non-related, or
cadaveric donor. Must be willing and able to give written informed consent. Aged between 18 and 65 years, inclusive. Subjects over the age of 65 may be considered on an individual basis based on medical suitability. Female subjects must be post-menopausal or surgically sterile, or using an acceptable method of contraception (oral contraceptives, Norplant, Depo-Provera, and barrier devices are acceptable; condoms used alone are not acceptable). WBC count must be greater than or equal to 3000/mm(2). No history of malignancy (except non-metastatic cutaneous squamous or basal cell carcinomas that have been completely excised without evidence of recurrence for at least 1 year). No active systemic bacterial, fungal or viral infections (including active zoster or herpetic lesions). No serological evidence of HIV, HCV, or HbsAg. No active peptic ulcer disease. No condition or circumstance that could potentially interfere with the evaluation of BG9588. No contraindication to monoclonal antibody therapies. No history of Major Thromboembolic event (e.g. stroke, pulmonary embolus). For the first 5 patients, no patient with a PRA greater than 20%. No previous participation in the study. No use of any investigational agent or device within 4 weeks prior to first dose of study drug. No Cold Ischemia Time of donor kidney greater than 36 hours. No uncontrolled non-heart-beating donor status. No positive T-cell Crossmatch. |
Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
Eggers PW. Effect of transplantation on the Medicare end-stage renal disease program. N Engl J Med. 1988 Jan 28;318(4):223-9. — View Citation
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. — View Citation
Morris PJ. Renal transplantation: a quarter century of achievement. Semin Nephrol. 1997 May;17(3):188-95. — View Citation
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