A Study To Test An Anti-Rejection Therapy After Kidney Transplantation

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

Renal transplantation is recognized as the treatment of choice for children with chronic renal failure. However, patient and graft survival rates in young children are unacceptably low. In preliminary studies, OKT3 (a monoclonal antibody) induction therapy received post transplant has been more successful than standard immunosuppression alone in improving graft survival. This study is designed to assess the impact of induction therapy on graft survival in pediatric kidney transplant patients.

Patients are assigned to OKT3 induction or no induction in a 1:1 ratio. Randomization to oral cycl...

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Children and young adults may be eligible for this study if they:
• • Are not yet 21 years of age.
• • Are receiving their first or second transplant.
• • Are not pregnant.
• • Agree to practice sexual abstinence or agree to use an effective
• • method of birth control/contraception during the study and
• • for 1 year after.
• • Exclusion Criteria
• Children and young adults will not be eligible for this study if they:
• • Are recipients of multiple organs other than kidneys.
• • Are recipients of three or more transplants.
• • Are HIV positive.
• • Are Hepatitis B surface antigen positive.