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Controlled Trial of Induction Therapy in Renal Transplantation

Phase 3
20 Years
Not Enrolling
Kidney Transplantation

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Trial Information

Controlled Trial of Induction Therapy in Renal Transplantation

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 cyclosporine of either Sandimmune or Neoral is also done in a 1:1 ratio. Group 1
receives OKT3 intraoperatively followed by Neoral. Group 2 receives OKT3 intraoperatively
followed by Sandimmune. OKT3 is administered at 2.5 mg (if weight less than 30 kg) or 5 mg
(if weight above 30 kg) per day for a maximum of 14 days. Group 3 receives IV cyclosporine
followed by Neoral. Group 4 receives IV cyclosporine followed by Sandimmune. Oral
cyclosporine is administered in a masked preparation. The dose for Sandimmune and Neoral is
the same; patients 6 years of age and older begin at a dose of 15 mg/kg/day and patients
under 6 years of age receive 500 mg/m2/day. Patients will receive concomitant medications
including steroids (IV and po), Nifedipine, anti-CMV therapy, Bactrim, Azathioprine or
Mycophenolate Mofetil. Kidney function, incidence of viral infection, graft survival, and
incidence of malignancy will be measured to assess the role of OKT3 induction and the role
of rejection in graft failure. Graft function will be evaluated at 1-, 2-, and 4-year

Inclusion 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.

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

To determine one-year graft function, as measured by graft survival and serum creatinine of children undregoing OKT3 induction versus no induction

Outcome Time Frame:

At 1 year

Safety Issue:



United States: Federal Government

Study ID:




Start Date:

November 1999

Completion Date:

March 2004

Related Keywords:

  • Kidney Transplantation



Ilene Blechman-Krom Rockville, Maryland  20850