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

NCT00000936 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 292

Last updated 2017-01-11

No results posted yet for this study

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

Interventions

DRUG

hOKT3

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

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.

DRUG

IV Cyclosporine

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

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-11-30
Completion
2004-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00000936 on ClinicalTrials.gov