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NCT02576145 · ClinicalTrials.gov registry record · Phase 4
A Study to Assess Immune Response in Pediatric Kidney Transplant Recipients Treated With Daclizumab (Zenapax)
A Phase 4 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 4
- Development phase
- 11
- Enrollment target
NCT02576145: Completed Phase 4 study, sponsored by Hoffmann-La Roche.
NCT02576145 is a Phase 4 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 11 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02576145, a Phase 4 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 11 participants
- Enrollment target
Study Summary
This study will assess whether daclizumab impairs the ability of children receiving a kidney transplant to elicit a primary immune response. The anticipated time on study treatment is 1 day, and the target sample size is 82 individuals.
Primary Outcome
Positive antibody response was defined as at least a 2-fold increase in antibody concentration on either Day 43 or Day 57 compared with baseline where baseline was assigned a value of 1 if it was below the limit of quantification. All humoral responses were assessed by enzyme-linked immunosorbent assay (ELISA).
Interventions
- DRUG Daclizumab
- BIOLOGICAL DT
- BIOLOGICAL KLH
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2003-04 |
| Est. Completion | 2006-01 |
| Phase | Phase 4 |
What the finished NCT02576145 record still lists
NCT02576145 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 3 interventions - of which Daclizumab is the first listed.
NCT02576145 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02576145 about?
NCT02576145 is a clinical study titled "A Study to Assess Immune Response in Pediatric Kidney Transplant Recipients Treated With Daclizumab (Zenapax)". This study will assess whether daclizumab impairs the ability of children receiving a kidney transplant to elicit a primary immune response. The anticipated time on study treatment is 1 day, and the target sample size is 82 individuals.
What is the current status of trial NCT02576145?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 11 participants. The study started on 2003-04. Estimated completion is 2006-01.
What interventions are being tested in trial NCT02576145?
The interventions under investigation include: Daclizumab (DRUG), DT (BIOLOGICAL), KLH (BIOLOGICAL).
Who is sponsoring clinical trial NCT02576145?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02576145's enrollment target sits among peer trials
11 1931st of 2000 higher than 61 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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