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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: Clinical Trial Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

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, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (106% higher). According to ClinicalTrials.gov, the official US trial registry.

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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 Doctors believe steroids might be safely withdrawn in patients that are receiving other maintenance therapies.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 This study evaluates whether steroid therapy can be withdrawn in a way that does not increase graft rejection.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

FieldValue
Enrollment Target 274 participants
Start Date 2001-01
Est. Completion 2005-06
Phase Phase 2

Why NCT00023244 stopped before completion

NCT00023244 is an interventional study that assigns participants to a tested intervention. The registered 274 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (106% higher).

The record links to 0 conditions, and to 5 interventions - of which Sirolimus is the first listed.

NCT00023244 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00023244's enrollment target sits among peer trials

274 203rd of 2000 higher than 1,797 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00023244, the US trial registry maintained by the National Library of Medicine. NCT00023244 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.