Study Of JAK3 Inhibitor For The Prevention Of Acute Rejection In Kidney Transplant Patients

This study has been withdrawn prior to enrollment.
Information provided by:
Pfizer Identifier:
First received: November 8, 2007
Last updated: May 27, 2008
Last verified: May 2008
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 cyclosporine will be given to new kidney transplant patients for 12 months in addition to other standard transplant medications such as prednisone.

Condition Intervention Phase
Kidney Transplantation
Drug: Cyclosporine
Drug: CP-690-,550
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Pilot Randomized, Multicenter, Open-Label, Active Comparator-Controlled Trial Of A CP-690,550-Based Regimen In De Novo Kidney Allograft Recipients

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Clinical biopsy proven acute rejection rate at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetics of CP-690,550 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Lymphocyte subsets [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Posttransplant humoral alloreactivity [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Safety and tolerability of CP-690,550 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: August 2007
Arms Assigned Interventions
Active Comparator: Treatment Arm 1
Treatment Arm 1 will also receive standard of care medications.
Drug: Cyclosporine
Standard of care
Experimental: Treatment Arm 2
Treatment Arm 2 will also receive select standard of care medications.
Drug: CP-690-,550
CP-690550 20 mg BID in Months 1-6 then 15 mg BID in Months 7-12


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

Inclusion Criteria:

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

Exclusion Criteria:

  • Recipient of any non-kidney transplant
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00556257

Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Identifier: NCT00556257     History of Changes
Other Study ID Numbers: A3921037 
Study First Received: November 8, 2007
Last Updated: May 27, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Immunosuppression, JAK3 inhibitor, kidney transplantation processed this record on May 25, 2016