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Pediatric Kidney Transplant Without Calcineurin Inhibitors

NCT00023231 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2016-10-21

No results posted yet for this study

Summary

The purpose of this study is to see the effect of using drugs other than calcineurin inhibitors to improve the rate of kidney transplant failure.

Kidney transplantation can help children with end-stage kidney disease. However, it has been difficult to find treatment for donor graft rejection that does not have a lot of side effects. Researchers hope to find treatments (immunosuppressants) with fewer side effects. One approach is to avoid using calcineurin inhibitors and to try a new drug known as sirolimus instead. Another is to use steroids less often. This study will test whether using sirolimus, fewer steroid treatments, MMF, and certain antibodies will improve long-term graft survival in children receiving kidney transplants from living donors.

Conditions

  • End-Stage Renal Disease

Interventions

DRUG

Daclizumab

1 mg/kg/dose at study entry and Weeks 2, 4, 6, and 8

DRUG

Methylprednisolone/prednisone

Dosage is dependent on weight and varies throughout study. Refer to protocol for more information.

DRUG

Mycophenolate mofetil

Solution or oral tablet taken daily. Dosage depends on body surface area.

DRUG

Sirolimus

Oral tablet taken once prior to transplant. Dosage dependent on body surface area.

DRUG

Bactrim

Oral tablet taken three times per week. Dosage is dependent on weight.

DRUG

Ganciclovir

Oral tablet taken daily. Dosage is dependent on weight.

DRUG

Lipitor

Oral tablet taken daily

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-02-28
Primary Completion
2004-08-31
Completion
2006-08-31

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 NCT00023231 on ClinicalTrials.gov