Safety & Efficacy of Certican in Pediatric de Novo Renal Transplant Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-06-30

Study Completion Date

2007-03-31

Brief Summary

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The purpose of this study is to evaluate the safety and tolerability of RAD001 (Certican) administered to pediatric renal transplant recipients, and to provide additional safety data.

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Detailed Description

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Conditions

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Kidney Transplantation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Certican

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male and female patients no more than 16 years of age.
* Patients receiving a primary cadaveric or non-HLA identical living donor (related or unrelated) renal transplant.
* The graft must be functional within 48 hours post transplantation.

Exclusion Criteria

* Cold ischemia time greater than 40 hours.
* Patients who are recipients of multiple solid organ transplants, including dual and en bloc kidneys, or who have previously received transplanted organs.
* Patients with panel reactive T cell antibodies of 50 % or higher at the last assessment before transplantation.

Minimum Eligible Age

1 Week

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No