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NCT00240994 · ClinicalTrials.gov registry record · Phase 2

Safety in Immunomodulatory Functions of Alemtuzumab (Campath) in Pediatric Kidney Transplantation Recipients

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

Completed
Registry status
Phase 2
Development phase
35
Enrollment target

NCT00240994: Completed Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

NCT00240994 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 35 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00240994, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 2
Development phase
35 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the safety of alemtuzumab after kidney transplantation as part of a multitherapy regimen to prevent kidney graft loss and death and to avoid steroids and chronic use of calcineurin inhibitors in pediatric renal transplant recipients 1 to 20 years of age.

Primary Outcome

Graft loss is defined as the need for dialysis for more than 30 days duration, allograft nephrectomy, or the decision to withdraw immunosuppression due to graft failure.

Interventions

  • DRUG Sirolimus
  • DRUG Alemtuzumab
  • DRUG Tacrolimus
  • DRUG Mycophenolate mofetil

Trial Details

FieldValue
Enrollment Target 35 participants
Start Date 2005-01
Est. Completion 2009-11
Phase Phase 2

What the finished NCT00240994 record still lists

NCT00240994 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower).

The record links to 0 conditions, and to 4 interventions - of which Sirolimus is the first listed.

NCT00240994 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00240994 about?

NCT00240994 is a clinical study titled "Safety in Immunomodulatory Functions of Alemtuzumab (Campath) in Pediatric Kidney Transplantation Recipients". The purpose of this study is to evaluate the safety of alemtuzumab after kidney transplantation as part of a multitherapy regimen to prevent kidney graft loss and death and to avoid steroids and chronic use of calcineurin inhibitors in pediatric renal transplant recipients 1 to 20 years of age.

What is the current status of trial NCT00240994?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 35 participants. The study started on 2005-01. Estimated completion is 2009-11.

What interventions are being tested in trial NCT00240994?

The interventions under investigation include: Sirolimus (DRUG), Alemtuzumab (DRUG), Tacrolimus (DRUG), Mycophenolate mofetil (DRUG).

Who is sponsoring clinical trial NCT00240994?

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 NCT00240994's enrollment target sits among peer trials

35 1524th of 2000 higher than 462 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 NCT00240994, the US trial registry maintained by the National Library of Medicine. NCT00240994 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.