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

NCT ID: NCT00000936

Last Updated: 2017-01-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 292 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-11-30
• Study Completion Date: 2004-03-31

Brief 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.

Detailed Description

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 intervals.

Conditions

Kidney Transplantation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Induction

subjects receiving hOKT3 induction therapy

Group Type: EXPERIMENTAL

hOKT3

Intervention Type: DRUG

Administered both during and after transplantation in IV form. Dosage determined by individual weight and given for a maximum of 14 days.

Oral Cyclosporine

Intervention Type: DRUG

Administered orally as either sandimmune or neoral at a dose determined by weight. 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, for the duration of the study.

Induction Free Therapy

Patients not receiving induction therapy

Group Type: ACTIVE_COMPARATOR

Oral Cyclosporine

Intervention Type: DRUG

Administered orally as either sandimmune or neoral at a dose determined by weight. 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, for the duration of the study.

IV Cyclosporine

Intervention Type: DRUG

Administered intravenously (IV) both during and after transplantation at a dosage determined by individual age.

Interventions

hOKT3

Administered both during and after transplantation in IV form. Dosage determined by individual weight and given for a maximum of 14 days.

Intervention Type: DRUG

Oral Cyclosporine

Administered orally as either sandimmune or neoral at a dose determined by weight. 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, for the duration of the study.

Intervention Type: DRUG

IV Cyclosporine

Administered intravenously (IV) both during and after transplantation at a dosage determined by individual age.

Intervention Type: DRUG

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.

• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ilene Blechman-Krom

Rockville, Maryland, United States

Countries

United States

Related Links

https://www.niaid.nih.gov/

The National Institute of Allergy and Infectious Diseases (NIAID)

https://www.niaid.nih.gov/about/dait

Division of Allergy, Immunology, and Transplantation (DAIT)

Other Identifiers

DAIT IN01/OLN-359

Identifier Type: -

Identifier Source: org_study_id