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Study of a JAK3 Inhibitor for the Prevention of Acute Rejection in Kidney Transplant Patients

NCT ID: NCT00483756

Last Updated: 2013-03-14

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

338 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2010-04-30

Brief Summary

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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. Patients will be assigned to one of three treatment groups after receiving a kidney transplant. Two of the treatment groups will receive 2 different dosing regimens of the JAK3 inhibitor that will be taken by mouth. The third treatment group will be a standard-of-care control arm. Patients will continue to take the assigned study medication for 12 months as well as other standard transplant medications such as prednisone.

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Detailed Description

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Conditions

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Kidney Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Treatment Arm 1 will also receive standard of care medications

Group Type ACTIVE_COMPARATOR

Cyclosporine

Intervention Type DRUG

Standard of care

2

Treatment Arm 2 will also receive standard of care medications

Group Type EXPERIMENTAL

CP-690,550

Intervention Type DRUG

CP-690,550 15 mg BID for Months 1-6, then 10 mg BID for Months 7-12

3

Treatment Arm 3 will also receive standard of care medications

Group Type EXPERIMENTAL

CP-690,550

Intervention Type DRUG

CP-690,550 15 mg BID for Months 1-3, then 10 mg BID for Months 4-12

Interventions

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Cyclosporine

Standard of care

Intervention Type DRUG

CP-690,550

CP-690,550 15 mg BID for Months 1-6, then 10 mg BID for Months 7-12

Intervention Type DRUG

CP-690,550

CP-690,550 15 mg BID for Months 1-3, then 10 mg BID for Months 4-12

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Little Rock, Arkansas, United States

Site Status

Pfizer Investigational Site

Los Angeles, California, United States

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Los Angeles, California, United States

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Palo Alto, California, United States

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San Diego, California, United States

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San Francisco, California, United States

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San Francisco, California, United States

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Stanford, California, United States

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Aurora, Colorado, United States

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New Haven, Connecticut, United States

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New Haven, Connecticut, United States

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Gainesville, Florida, United States

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Gainsville, Florida, United States

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Tampa, Florida, United States

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Chicago, Illinois, United States

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Chicago, Illinois, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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Springfield, Massachusetts, United States

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Springfield, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Detroit, Michigan, United States

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Rochester, Minnesota, United States

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St Louis, Missouri, United States

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Livingston, New Jersey, United States

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New York, New York, United States

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Valhalla, New York, United States

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Chapel Hill, North Carolina, United States

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Chapel Hill, North Carolina, United States

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Chapel Hill, North Carolina, United States

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Chapel Hill, North Carolina, United States

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Portland, Oregon, United States

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Philadelphia, Pennsylvania, United States

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Charleston, South Carolina, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Fort Worth, Texas, United States

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Camperdown, New South Wales, Australia

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Westmead, New South Wales, Australia

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Adelaide, South Australia, Australia

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Woodville, South Australia, Australia

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Clayton, Victoria, Australia

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Parkville, Victoria, Australia

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Anderlecht, , Belgium

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Leuven, , Belgium

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Porto Alegre, Rio Grande do Sul, Brazil

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São Paulo, São Paulo, Brazil

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São Paulo, São Paulo, Brazil

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Edmonton, Alberta, Canada

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Prague, , Czechia

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Nantes, , France

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Paris, , France

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Toulouse, , France

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Vandœuvre-lès-Nancy, , France

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Berlin, , Germany

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Hamburg, , Germany

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Bologna, , Italy

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Roma, , Italy

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Rotterdam, , Netherlands

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Oslo, , Norway

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Warsaw, , Poland

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Wroclaw, , Poland

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Coimbra, , Portugal

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Lisbon, , Portugal

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Pfizer Investigational Site

Barcelona, Barcelona, Spain

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Pfizer Investigational Site

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status

Countries

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United States Australia Belgium Brazil Canada Czechia France Germany Italy Netherlands Norway Poland Portugal South Korea Spain

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3921030&StudyName=Study%20of%20a%20JAK3%20Inhibitor%20for%20the%20Prevention%20of%20Acute%20Rejection%20in%20Kidney%20Transplant%20Patients

To obtain contact information for a study center near you, click here.

Other Identifiers

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A3921030

Identifier Type: -

Identifier Source: org_study_id

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