Extension Study Of Stage 1 Subjects Of Study A3921009 For The Prevention Of Acute Rejection In Kidney Transplant Patient
Public ClinicalTrials.gov record NCT00263328. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Phase 2, Open-label, Controlled, Extension Study For Stage 1 Subjects Of Study A3921009 To Evaluate The Long-term Safety And Efficacy Of Cp-690,550 Versus Tacrolimus, When Co-administered With Mycophenolate Mofetil In Renal Allograft Recipients
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00263328
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 46 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 70 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 2005 (Type not available)
- Primary completion
- Jan 2014 (Actual)
- Completion
- Jun 2014 (Actual)
- Last update posted
- Jul 13, 2015
2005 – 2014
United States locations
- U.S. sites
- 27
- U.S. states
- 8
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Multi Organ Transplant Center | Los Angeles | California | 90057 | — |
| St. Vincent Medical Center | Los Angeles | California | 90057 | — |
| Transplant Research Institute | Los Angeles | California | 90057 | — |
| Stanford School of Medicine | Palo Alto | California | 94304 | — |
| Balboa Institute of Transplantation | San Diego | California | 92123 | — |
| California Institute of Renal Research | San Diego | California | 92123 | — |
| Sharp Memorial Hospital | San Diego | California | 92123 | — |
| California Pacific Medical Center | San Francisco | California | 94115 | — |
| University of California, San Francisco, Kidney Transplant Unit | San Francisco | California | 94143 | — |
| Stanford University Medical Center | Stanford | California | 94305 | — |
| University of Colorado Health Sciences Center Renal Clinical Trials Office | Aurora | Colorado | 80045 | — |
| University of Colorado Health Sciences Center | Aurora | Colorado | 80045 | — |
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | — |
| Northwestern University-Feinberg School of Medicine, Division of Organ Transplantation | Chicago | Illinois | 60611 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Jack J Dreyfus Clinic | New York | New York | 10021 | — |
| Recanati/Miller Transplantation Institute | New York | New York | 10029 | — |
| New York Presbyterian Hospital / Weill Cornell Medical Center | New York | New York | 10065 | — |
| Legacy Good Samaritan Hospital | Portland | Oregon | 97210 | — |
| Legacy Transplant Services | Portland | Oregon | 97210 | — |
| Northwest Renal Clinic | Portland | Oregon | 97210 | — |
| Dallas Transplant Institute | Dallas | Texas | 75204 | — |
| Annette C & Harold C Simmons Transplant Institute | Dallas | Texas | 75246 | — |
| Baylor University Medical Center | Dallas | Texas | 75246 | — |
| Baylor All Saints Medical Center | Fort Worth | Texas | 76104 | — |
| Froedtert Memorial Lutheran Hospital | Milwaukee | Wisconsin | 53226 | — |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00263328, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 13, 2015 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00263328 live on ClinicalTrials.gov.