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

Launched by NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES (NIDDK) · Dec 9, 2002

Keywords

ClinConnect Summary

This protocol is an open label, non-randomized study designed to test whether treatment with BG9588, a humanized monoclonal antibody specific for CD154, can induce a state of allograft tolerance following renal allotransplantation in humans. This study is designed to primarily assess the safety and efficacy of BG9588 when given alone or in combination with steroids and mycophenolate to prevent renal allograft rejection without the use of calcineurin inhibitors or other chronic anti-rejection therapies. Efficacy parameters will include the incidence of acute and chronic rejection episodes, a...

Gender

ALL

Eligibility criteria

• • 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.