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NCT00543569 · ClinicalTrials.gov registry record · Phase 2
A Study to Assess the Safety and Efficacy of Alefacept in Kidney Transplant Recipients
A Phase 2 study of Kidney Transplantation, sponsored by Astellas Pharma.
- Completed
- Registry status
- Phase 2
- Development phase
- 323
- Enrollment target
- 20
- Study locations
NCT00543569: Completed Phase 2 study of Kidney Transplantation, sponsored by Astellas Pharma.
NCT00543569 is a Phase 2 study of Kidney Transplantation that has completed, run by Astellas Pharma. The registered enrollment target is 323 participants, above the 258-participant average among 33 other Kidney Transplantation trials with a reported enrollment target (25% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00543569, a Phase 2 study of Kidney Transplantation, has completed, sponsored by Astellas Pharma.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 323 participants
- Enrollment target
- 20
- Study locations
Study Summary
A study to assess the safety and efficacy of Alefacept in de novo kidney transplant patients.
Primary Outcome
Rejection episodes were confirmed by biopsy by the clinical site pathologist. Biopsies were graded according to the 2005 Banff criteria. All biopsies (T-cell and/or antibody mediated) of grade 1 or higher were considered a BCAR. The Kaplan-Meier estimates at Day 182 was used for the analyses at 6 months. Lost to follow-up or patients with missing outcomes were censored at their last follow up visit.
Conditions Studied
Interventions
- DRUG Corticosteroids
- DRUG tacrolimus
- DRUG mycophenolate mofetil
- DRUG basiliximab
- DRUG Alefacept
Study Locations (20)
California
- Loma Linda University Medical Center - Loma Linda
- University of Southern California - University Hospital - Los Angeles
- St. Vincent/National Institute of Transplantation - Los Angeles
- UC Davis Medical Center - Sacramento
- UCSD - San Diego
- California Institute of Renal Research/Sharp Memorial Hospital - San Diego
- University of California - San Francisco - San Francisco
Illinois
- Rush - Presbyterian - St. Lukes Medical Center - Chicago
- University of Illinois at Chicago - Chicago
- University of Chicago Medical Center - Chicago
Florida
- University of Florida, Shands Hospital, Gainesville - Gainesville
- Mayo Clinic - Jacksonville - Jacksonville
Massachusetts
- Tufts Medical Center - Boston
- Brigham and Women's Hospital - Boston
Colorado
- University of Colorado Health Science Center - Aurora
Georgia
- Medical College of Georgia, Augusta - Augusta
Kentucky
- University of Kentucky - Lexington
Maryland
- University of Maryland Center - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 323 participants |
| Start Date | 2008-02 |
| Est. Completion | 2011-02 |
| Phase | Phase 2 |
What the finished NCT00543569 record still lists
NCT00543569 is an interventional study that assigns participants to a tested intervention. The registered 323 participants enrollment target is mid-sized for trials with a published cap, above the 258-participant average among 33 other Kidney Transplantation trials with a reported enrollment target (25% higher).
The record links to 1 condition, with Kidney Transplantation appearing as the primary indexed condition, and to 5 interventions - of which Corticosteroids is the first listed.
NCT00543569 names 20 study sites across 10 states, led by California, Illinois, Florida.
Frequently Asked Questions
What is clinical trial NCT00543569 about?
NCT00543569 is a clinical study titled "A Study to Assess the Safety and Efficacy of Alefacept in Kidney Transplant Recipients". A study to assess the safety and efficacy of Alefacept in de novo kidney transplant patients.
What is the current status of trial NCT00543569?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 323 participants. The study started on 2008-02. Estimated completion is 2011-02.
What conditions does trial NCT00543569 study?
This clinical trial studies the following conditions: Kidney Transplantation.
What interventions are being tested in trial NCT00543569?
The interventions under investigation include: Corticosteroids (DRUG), tacrolimus (DRUG), mycophenolate mofetil (DRUG), basiliximab (DRUG), Alefacept (DRUG).
Who is sponsoring clinical trial NCT00543569?
This trial is sponsored by Astellas Pharma, which has 165 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00543569 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Kidney Transplantation
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00543569's enrollment target sits among peer trials
323 8th of 33 higher than 26 of 33 other Kidney Transplantation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Kidney Transplantation 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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