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Study of 2 Dose Levels of a JAK3 Inhibitor for the Prevention of Acute Rejection in Kidney Transplant Patients
This study has been completed.
First Received: March 28, 2005   Last Updated: October 12, 2006   History of Changes
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Biopsy Proven Acute Rejection rate at 6 months Glomerular Filtration rate at 6 months

Estimated Enrollment: 249
Study Start Date: May 2005
Estimated Study Completion Date: July 2006
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Recipient of a first-time kidney transplant
  • Between the ages of 18 and 70 years, inclusive

Exclusion Criteria:

  • Recipient of any non-kidney transplant
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00106639

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
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):
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

ClinicalTrials.gov processed this record on February 08, 2010