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

NCT00001857 | Completed Phase 2

• 2 other identifiers: 99010999-DK-0109
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Kidney Transplantation

Keywords

Costimulation; Immunosuppression; Tolerance

Interventions

BG9588 DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead

Study Sites (1)

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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.

  PMID: 3275896 BACKGROUND

• Morris PJ. Renal transplantation: a quarter century of achievement. Semin Nephrol. 1997 May;17(3):188-95.

  PMID: 9165648 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.

  PMID: 9679818 BACKGROUND

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: December 10, 2002
• Study Start: May 1, 1999
• Study Completion: April 1, 2000
• Last Updated: March 4, 2008

Record last verified: 1999-05

Locations

US (1)