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A Study to Compare Treatment With Sirolimus Versus Standard Treatment in Patients Who Have Received a Kidney Transplant

NCT00005113 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2012-03-13

No results posted yet for this study

Summary

The purpose of this study is to compare treatment with the new drug sirolimus (SRL) versus the standard treatment with cyclosporine (CsA) or tacrolimus in children who have received kidney transplants. SRL is a new medication that may prevent the body's immune system from rejecting organ transplants.

After receiving a kidney transplant, the body recognizes the donated kidney as a foreign invader and triggers the immune system to attack the kidney. This can lead to rejection of the new kidney and a failed transplant. To help reduce the risk of kidney rejection, transplant patients are given immunosuppressant drugs, which reduce the body's normal immune response and allow the transplanted organ to function. CsA or tacrolimus are two drugs that are often given to transplant patients. However, these are powerful drugs, and it can cause serious side effects and put a patient at increased risk for infections. SRL is a new drug that has been shown to reduce a transplant patient's chance of rejecting a new kidney, without serious side effects. This study is necessary to test the safety and effectiveness of SRL in children.

Conditions

  • End-Stage Renal Disease
  • Kidney Transplantation

Interventions

DRUG

Cyclosporine

Oral tablet taken daily. Dosage is dependent on weight and is titrated to target trough level.

DRUG

Sirolimus

Dosage in liquid or tablet form is dependent on body surface area and is titrated to target trough level.

DRUG

Tacrolimus

dosage is in oral form titrated to target trough level

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-07-31
Primary Completion
2004-07-31
Completion
2006-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT00005113 on ClinicalTrials.gov