|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Pfizer |
|---|---|
| Information provided by: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00106639 |
Purpose
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 this research study, a JAK3 inhibitor or tacrolimus will be given to new kidney transplant patients for 6 months. Patients who respond well will be offered the opportunity to participate in an additional study to receive the JAK3 inhibitor or tacrolimus long-term. There will be 2 stages of enrollment in this study. In both stages of this research study, patients will be assigned to one of three treatment groups from the day after receiving a kidney transplant. Two of the treatment groups will be 2 different dose levels of the JAK3 inhibitor that will be taken by mouth. The third treatment group will be twice daily tacrolimus (Prograf). Patients will continue to take the assigned study medication (JAK3 inhibitor or tacrolimus) for 6 months as well as other standard transplant medications such as Cellcept and prednisone.
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Transplantation |
Drug: CP-690,550 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A 6-Month, Phase 2, Multicenter, Randomized, Open-Label, Comparative Study of 2 Dose Levels of CP-690,550 Administered Concomitantly With il-2 Receptor Antagonist Induction Therapy, Mycophenolate Mofetil and Corticosteroids Versus a Tacrolimus-Based Immunosuppressive Regimen for the Prevention of Allograft Rejection in de Novo Renal Allograft Recipients |
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| Pfizer Investigational Site | |
| San Diego, California, United States, 92123 | |
| Pfizer Investigational Site | |
| SAN DIEGO, California, United States, 92123 | |
| Pfizer Investigational Site | |
| Palo Alto, California, United States, 94304 | |
| Pfizer Investigational Site | |
| Stanford, California, United States, 94305 | |
| Pfizer Investigational Site | |
| Los Angeles, California, United States, 90057 | |
| Pfizer Investigational Site | |
| Los Angeles, California, United States, 92356 | |
| Pfizer Investigational Site | |
| San Francisco, California, United States, 94115 | |
| 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, Louisiana | |
| Pfizer Investigational Site | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Missouri | |
| Pfizer Investigational Site | |
| St. Louis, Missouri, United States, 63110 | |
| Pfizer Investigational Site | |
| St. Louis, Missouri, United States, 63110-1092 | |
| United States, New Jersey | |
| Pfizer Investigational Site | |
| Livingston, New Jersey, United States, 07039 | |
| 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, Virginia | |
| Pfizer Investigational Site | |
| Richmond, Virginia, United States, 23298 | |
| United States, Wisconsin | |
| Pfizer Investigational Site | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
| Study ID Numbers: | A3921009 |
| Study First Received: | March 28, 2005 |
| Last Updated: | October 12, 2006 |
| ClinicalTrials.gov Identifier: | NCT00106639 History of Changes |
| Health Authority: | United States: Food and Drug Administration |