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NCT00263328 · ClinicalTrials.gov registry record · Phase 2
Extension Study Of Stage 1 Subjects Of Study A3921009 For The Prevention Of Acute Rejection In Kidney Transplant Patient
A Phase 2 study of Kidney Transplantation, sponsored by Pfizer.
- Completed
- Registry status
- Phase 2
- Development phase
- 46
- Enrollment target
- 20
- Study locations
NCT00263328: Completed Phase 2 study of Kidney Transplantation, sponsored by Pfizer.
NCT00263328 is a Phase 2 study of Kidney Transplantation that has completed, run by Pfizer. The registered enrollment target is 46 participants, below the 267-participant average among 33 other Kidney Transplantation trials with a reported enrollment target (83% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00263328, a Phase 2 study of Kidney Transplantation, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 46 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was calculated using MDRD equation. GFR by MDRD equation = 170 \* (serum creatinine \[in milligrams per deciliter (mg/dL)\])\^(-0.999) \* (age in years)\^(-0.176) \* (0.762 if female) \* (1.18 if black) \* (blood urea nitrogen \[BUN\] concentration \[mg/dL\])\^(-0.170) \* (serum albumin concentration \[in grams per dL (g/dL)\])\^(0.318). A normal GFR is \>90 milliliters per minute per 1.73 squ
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 |
What the finished NCT00263328 record still lists
NCT00263328 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 267-participant average among 33 other Kidney Transplantation trials with a reported enrollment target (83% lower).
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.
NCT00263328 names 20 study sites across 6 states, led by California, New York, Colorado.
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.
What interventions are being tested in trial NCT00263328?
The interventions under investigation include: Tacrolimus (DRUG), CP-690,550 (DRUG).
Who is sponsoring clinical trial NCT00263328?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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.
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 NCT00263328's enrollment target sits among peer trials
46 24th of 33 higher than 10 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.
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