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

• Status: Terminated
• Trial end date: 2004-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Kidney transplantation is often successful. However, despite aggressive anti-rejection drug therapy, some patients will reject their new kidney. This study is designed to test two anti-rejection approaches. Two medications in this study are currently used in children, but there is no information regarding which drug is safer or more effective.

Survival rates in renal transplantation are unacceptably low. Therefore, there is a need for an improved post-transplant treatment, such as the induction therapy used in this study.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Cyclosporine; Cyclosporins

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.