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

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ClinicalTrials.gov Identifier: NCT00556257
Recruitment Status : Withdrawn
First Posted : November 9, 2007
Last Update Posted : May 30, 2008
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Kidney Transplantation Drug: Cyclosporine Drug: CP-690-,550 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : August 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Clinical biopsy proven acute rejection rate at 6 months [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Pharmacokinetics of CP-690,550 [ Time Frame: 12 months ]
  2. Lymphocyte subsets [ Time Frame: 12 months ]
  3. Posttransplant humoral alloreactivity [ Time Frame: 12 months ]
  4. Safety and tolerability of CP-690,550 [ Time Frame: 12 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00556257


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

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer
ClinicalTrials.gov Identifier: NCT00556257     History of Changes
Other Study ID Numbers: A3921037
First Posted: November 9, 2007    Key Record Dates
Last Update Posted: May 30, 2008
Last Verified: May 2008

Keywords provided by Pfizer:
Immunosuppression, JAK3 inhibitor, kidney transplantation

Additional relevant MeSH terms:
Cyclosporins
Cyclosporine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors