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

NCT00483756

Last updated date
Study Location
Pfizer Investigational Site
Little Rock, Arkansas, 72205, United States
Contact
1-800-718-1021

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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Kidney Transplantation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Recipient of a first-time kidney transplant

- Between the ages of 18 and 70 years, inclusive

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Recipient of any non-kidney transplant

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study of a JAK3 Inhibitor for the Prevention of Acute Rejection in Kidney Transplant Patients
Official Title  ICMJE A Phase 2 Randomized, Multicenter, Active Comparator-Controlled Trial to Evaluate the Safety and Efficacy of Co-administration of CP-690,550 and Mycophenolate Mofetil / Mycophenolate Sodium in De Novo Renal Allograft Recipients
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. 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Kidney Transplantation
Intervention  ICMJE
  • Drug: Cyclosporine
    Standard of care
  • Drug: CP-690,550
    CP-690,550 15 mg BID for Months 1-6, then 10 mg BID for Months 7-12
  • Drug: CP-690,550
    CP-690,550 15 mg BID for Months 1-3, then 10 mg BID for Months 4-12
Study Arms  ICMJE
  • Active Comparator: 1
    Treatment Arm 1 will also receive standard of care medications
    Intervention: Drug: Cyclosporine
  • Experimental: 2
    Treatment Arm 2 will also receive standard of care medications
    Intervention: Drug: CP-690,550
  • Experimental: 3
    Treatment Arm 3 will also receive standard of care medications
    Intervention: Drug: CP-690,550
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 8, 2013)
338
Original Enrollment  ICMJE
 (submitted: June 6, 2007)
300
Actual Study Completion Date  ICMJE April 2010
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Brazil,   Canada,   Czech Republic,   France,   Germany,   Italy,   Korea, Republic of,   Netherlands,   Norway,   Poland,   Portugal,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00483756
Other Study ID Numbers  ICMJE A3921030
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date February 2013

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