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Extension Study Of Stage 1 Subjects Of Study A3921009 For The Prevention Of Acute Rejection In Kidney Transplant Patient
NCT00263328 · View on ClinicalTrials.gov ↗
Study Summary
A new immunosuppressive drug, based on the inhibition of an important enzyme in the immune system called JAK3, is being developed by Pfizer to prevent transplant rejection. In study A3921009, kidney transplant patients were given a JAK inhibitor or tacrolimus for 6 months posttransplant. Patients who completed study A3921009 were offered the opportunity to participate in study A3921021 which will extend the evaluation of safety and efficacy of CP-690,550 versus tacrolimus through 8 years posttransplant. In treatment group 1 (control arm), subjects will continue to receive tacrolimus. In treatment groups 2 and 3, subjects will continue to receive CP-690,550. Per Amendment 4, the tacrolimus comparator arm will be discontinued.
Conditions Studied
Interventions
- DRUG Tacrolimus
- DRUG CP-690,550
Study Locations (20)
California
- Multi Organ Transplant Center — Los Angeles
- St. Vincent Medical Center — Los Angeles
- Transplant Research Institute — Los Angeles
- Stanford School of Medicine — Palo Alto
- Balboa Institute of Transplantation — San Diego
- California Institute of Renal Research — San Diego
- Sharp Memorial Hospital — San Diego
- California Pacific Medical Center — San Francisco
- University of California, San Francisco, Kidney Transplant Unit — San Francisco
- Stanford University Medical Center — Stanford
New York
- Jack J Dreyfus Clinic — New York
- Recanati/Miller Transplantation Institute — New York
- New York Presbyterian Hospital / Weill Cornell Medical Center — New York
Colorado
- University of Colorado Health Sciences Center Renal Clinical Trials Office — Aurora
- University of Colorado Health Sciences Center — Aurora
Illinois
- Northwestern Memorial Hospital — Chicago
- Northwestern University-Feinberg School of Medicine, Division of Organ Transplantation — Chicago
Oregon
- Legacy Good Samaritan Hospital — Portland
- Legacy Transplant Services — Portland
Missouri
- Washington University School of Medicine — St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2005-12 |
| Est. Completion | 2014-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00263328
The ClinicalTrials.gov registry entry for NCT00263328 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 769 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Kidney Transplantation appearing as the primary indexed condition, and to 2 interventions — of which Tacrolimus is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00263328 reports 20 study locations spanning 6 distinct geographic areas — top geographies include California, New York, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00263328 about?
NCT00263328 is a clinical study titled "Extension Study Of Stage 1 Subjects Of Study A3921009 For The Prevention Of Acute Rejection In Kidney Transplant Patient". A new immunosuppressive drug, based on the inhibition of an important enzyme in the immune system called JAK3, is being developed by Pfizer to prevent transplant rejection. In study A3921009, kidney transplant patients were given a JAK inhibitor or tacrolimus for 6 months posttransplant. Patients wh...
What is the current status of trial NCT00263328?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 46 participants. The study started on 2005-12. Estimated completion is 2014-06.
What conditions does trial NCT00263328 study?
This clinical trial studies the following conditions: Kidney Transplantation. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00263328?
The interventions under investigation include: Tacrolimus (DRUG), CP-690,550 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00263328?
This trial is sponsored by Pfizer, which has 769 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00263328 being conducted?
This trial has 20 study locations across California, Colorado, Illinois, Missouri, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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