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NCT00023244 · ClinicalTrials.gov registry record · Phase 2
Steroid Withdrawal in Pediatric Kidney Transplant Recipients
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Terminated
- Registry status
- Phase 2
- Development phase
- 274
- Enrollment target
NCT00023244 is a Phase 2 study that was terminated before completion, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 274 participants.
The verdict
NCT00023244, a Phase 2 study, was terminated before completion, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 274 participants
- Enrollment target
Study Summary
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 Doctors believe steroids might be safely withdrawn in patients that are receiving other maintenance therapies.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 This study evaluates whether steroid therapy can be withdrawn in a way that does not increase graft rejection.
Interventions
- DRUG Sirolimus
- DRUG Methylprednisolone
- DRUG Tacrolimus
- DRUG Cyclosporine
- DRUG Basiliximab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 274 participants |
| Start Date | 2001-01 |
| Est. Completion | 2005-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00023244
The ClinicalTrials.gov registry entry for NCT00023244 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 274 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Sirolimus is the first listed.
NCT00023244 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00023244 about?
NCT00023244 is a clinical study titled "Steroid Withdrawal in Pediatric Kidney Transplant Recipients". 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...
What is the current status of trial NCT00023244?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 274 participants. The study started on 2001-01. Estimated completion is 2005-06.
What interventions are being tested in trial NCT00023244?
The interventions under investigation include: Sirolimus (DRUG), Methylprednisolone (DRUG), Tacrolimus (DRUG), Cyclosporine (DRUG), Basiliximab (DRUG).
Who is sponsoring clinical trial NCT00023244?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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