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

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00556257
First Posted: November 9, 2007
Last Update Posted: May 30, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
November 8, 2007
November 9, 2007
May 30, 2008
August 2007
Not Provided
Clinical biopsy proven acute rejection rate at 6 months [ Time Frame: 6 months ]
Clinical biopsy proven acute rejection rate at 6 months
Complete list of historical versions of study NCT00556257 on ClinicalTrials.gov Archive Site
  • Pharmacokinetics of CP-690,550 [ Time Frame: 12 months ]
  • Lymphocyte subsets [ Time Frame: 12 months ]
  • Posttransplant humoral alloreactivity [ Time Frame: 12 months ]
  • Safety and tolerability of CP-690,550 [ Time Frame: 12 months ]
  • Safety and tolerability of CP-690,550
  • Pharmacokinetics of CP-690,550
  • Lymphocyte subsets
  • Posttransplant humoral alloreactivity
Not Provided
Not Provided
 
Study Of JAK3 Inhibitor For The Prevention Of Acute Rejection In Kidney Transplant Patients
A Pilot Randomized, Multicenter, Open-Label, Active Comparator-Controlled Trial Of A CP-690,550-Based Regimen In De Novo Kidney Allograft Recipients
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Kidney Transplantation
  • Drug: Cyclosporine
    Standard of care
  • Drug: CP-690-,550
    CP-690550 20 mg BID in Months 1-6 then 15 mg BID in Months 7-12
  • Active Comparator: Treatment Arm 1
    Treatment Arm 1 will also receive standard of care medications.
    Intervention: Drug: Cyclosporine
  • Experimental: Treatment Arm 2
    Treatment Arm 2 will also receive select standard of care medications.
    Intervention: Drug: CP-690-,550
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
Not Provided
Not Provided

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT00556257
A3921037
Yes
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP