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

NCT00000936 | Terminated Phase 3

• 1 other identifier: DAIT IN01/OLN-359
• Study Type: interventional
• Target: 292
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Transplantation

Outcome Measures

Primary Outcomes (2)

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

  At 1 year

• To compare the efficacy of Sandimmune and Neoral with respect to graft function

  Throughout study

Secondary Outcomes (8)

• Two and four-year graft functions

  At 2 and 4 years

• Safety with respect to viral infections and malignancies in children undergoing a renal transplant

  Throughout study

• Frequency and severity of rejection episodes

  Throughout study

• Time to first rejection

  Throughout study

• Length and frequency of hospitalization

  Throughout study

Study Arms (2)

Induction

EXPERIMENTAL

subjects receiving hOKT3 induction therapy

Drug: hOKT3; Drug: Oral Cyclosporine

Induction Free Therapy

ACTIVE COMPARATOR

Patients not receiving induction therapy

Drug: Oral Cyclosporine; Drug: IV Cyclosporine

Interventions

hOKT3 DRUG

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

Induction

Oral Cyclosporine 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; Induction Free Therapy

IV Cyclosporine DRUG

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

Induction Free Therapy

Eligibility Criteria

• Age: Up to 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Ilene Blechman-Krom

Rockville, Maryland, 20850, United States

Location

Related Links

• The National Institute of Allergy and Infectious Diseases (NIAID)
• Division of Allergy, Immunology, and Transplantation (DAIT)

MeSH Terms

Interventions

Cyclosporine

Intervention Hierarchy (Ancestors)

Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Start: November 1, 1999
• Study Completion: March 1, 2004
• Last Updated: January 11, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)