Steroid Withdrawal in Pediatric Kidney Transplant Recipients
Public ClinicalTrials.gov record NCT00023244. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Double-Blind Randomized Trial of Steroid Withdrawal in Sirolimus- and Cyclosporine-Treated Primary Transplant Recipients
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to examine the effects of withdrawing steroids on graft rejection and kidney functions in kidney transplant recipients between the ages of 0 and 20 years (prior to their 21st birthday). Graft survival has improved in recent years in children with kidney transplants. One bad side effect of steroid maintenance therapy has been growth retardation. Doctors believe steroids might be safely withdrawn in patients that are receiving other maintenance therapies. If steroids are removed, children might catch up in their growth and also might have fewer side effects of other kinds. This study evaluates whether steroid therapy can be withdrawn in a way that does not increase graft rejection.
Study identification
- NCT ID
- NCT00023244
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 274 participants
Conditions and interventions
Conditions
Interventions
- Basiliximab Drug
- Cyclosporine Drug
- Tacrolimus Drug
- Sirolimus Drug
- Methylprednisolone Drug
- Prednisone Drug
- Bactrim Drug
Drug
Eligibility (public fields only)
- Age range
- 1 Day to 20 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 2001 (Type not available)
- Primary completion
- Jun 2005 (Actual)
- Completion
- Jun 2005 (Actual)
- Last update posted
- Oct 21, 2016
2001 – 2005
United States locations
- U.S. sites
- 18
- U.S. states
- 16
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35233 | — |
| UCSD Medical Center | San Diego | California | 92103 | — |
| Denver Children's Hospital | Aurora | Colorado | 80045 | — |
| University of Florida Health Science Center | Jacksonville | Florida | 32209 | — |
| Emory Children's Center | Atlanta | Georgia | 30322 | — |
| Tulane University Medical Center | New Orleans | Louisiana | 70112 | — |
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | — |
| Children's Hospital of Boston | Boston | Massachusetts | 02115 | — |
| University of New Mexico Health Science Center | Albuquerque | New Mexico | 87131 | — |
| The Children's Hospital of Buffalo | Buffalo | New York | 14222 | — |
| Westchester Medical Center | Valhalla | New York | 10595 | — |
| Rainbow Babies and Childrens Hospital | Cleveland | Ohio | 44106 | — |
| University Hospitals of Cleveland | Cleveland | Ohio | 44106 | — |
| Penn State College of Medicine | Hershey | Pennsylvania | 17033 | — |
| LeBonheur Children's Medical Center | Memphis | Tennessee | 38103 | — |
| Christopher Goldsbury Center | San Antonio | Texas | 78207 | — |
| Children's Hospital and Regional Medical Center | Seattle | Washington | 98105 | — |
| University of Wisconsin | Madison | Wisconsin | 53705 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00023244, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 21, 2016 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00023244 live on ClinicalTrials.gov.