Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Pfizer |
---|---|
Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00263328 |
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 JAK3 inhibitor or tacrolimus for 6 months posttransplant. Patients who responded well in 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.
Condition | Intervention | Phase |
---|---|---|
Kidney Transplantation |
Drug: Tacrolimus Drug: CP-690,550 |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 54 |
Study Start Date: | July 2005 |
Estimated Study Completion Date: | February 2014 |
Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Treatment group 1: Active Comparator
Standard of care
|
Drug: Tacrolimus
Standard of care
|
Treatment group 2: Experimental
Treatment group 2 also receives mycophenolate mofetil
|
Drug: CP-690,550
CP-690,550 5 mg BID
|
Treatment group 3: Experimental |
Drug: CP-690,550
CP-690,550 10 mg BID
|
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Pfizer Investigational Site | |
San Diego, California, United States, 92123 | |
Pfizer Investigational Site | |
Palo Alto, California, United States, 94304 | |
Pfizer Investigational Site | |
Los Angeles, California, United States, 90057 | |
Pfizer Investigational Site | |
San Francisco, California, United States, 94115 | |
Pfizer Investigational Site | |
San Francisco, California, United States, 94143 | |
Pfizer Investigational Site | |
San Francisco, California, United States, 94143-0780 | |
United States, Colorado | |
Pfizer Investigational Site | |
Denver, Colorado, United States, 80262 | |
United States, Illinois | |
Pfizer Investigational Site | |
Chicago, Illinois, United States, 60611 | |
United States, Missouri | |
Pfizer Investigational Site | |
St. Louis, Missouri, United States, 63110 | |
United States, New York | |
Pfizer Investigational Site | |
New York, New York, United States, 10029 | |
Pfizer Investigational Site | |
New York, New York, United States, 10021 | |
United States, Oregon | |
Pfizer Investigational Site | |
Portland, Oregon, United States, 97210 | |
United States, Texas | |
Pfizer Investigational Site | |
Dallas, Texas, United States, 75204 | |
Pfizer Investigational Site | |
Dallas, Texas, United States, 75246 | |
United States, Wisconsin | |
Pfizer Investigational Site | |
Milwaukee, Wisconsin, United States, 53226 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A3921021 |
Study First Received: | December 6, 2005 |
Last Updated: | January 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00263328 |
Health Authority: | United States: Food and Drug Administration |
immunosuppression, JAK3 inhibitor, and kidney transplantation |
Mycophenolate mofetil Tacrolimus |
Immunologic Factors Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions |