A 6-Month Study Of CP-690,550 Versus Tacrolimus In Kidney Transplant Patients

NCT00106639

Last updated date
Study Location
Pfizer Investigational Site
Los Angeles, California, 90057, United States
Contact
1-800-718-1021

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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 A 6-Month Study Of CP-690,550 Versus Tacrolimus In Kidney Transplant Patients
Official Title  ICMJE A 6-Month, Phase 2, Multicenter, Randomized, Open-Label, Comparative Study Of 2 Dose Levels Of CP-690,550 Administered Concomitantly With IL-2 Receptor Antagonist Induction Therapy, Mycophenolate Mofetil And Corticosteroids Versus A Tacrolimus-Based Immunosuppressive Regimen For The Prevention Of Allograft Rejection In De Novo Renal Allograft Recipients
Brief Summary This Phase 2 study was designed to evaluate the safety and efficacy of 2 dose levels of CP-690,550 (15 mg twice daily and 30 mg twice) against tacrolimus, in combination with basiliximab induction, mycophenolate mofetil and corticosteroids, in kidney transplant patients. Stage 1 was to randomize approximately 54 subjects. After all Stage 1 subjects had completed 6 months of treatment, Stage 2 was to randomize an additional 195 subjects to the same treatment groups.
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: CP-690,550
    15 mg twice daily
  • Drug: CP-690,550
    30 mg twice daily
  • Drug: tacrolimus
    dose adjusted according to level
Study Arms  ICMJE
  • Experimental: CP-690,550 15 mg BID
    Intervention: Drug: CP-690,550
  • Experimental: CP-690,550 30 mg BID
    Intervention: Drug: CP-690,550
  • Active Comparator: tacrolimus
    Intervention: Drug: tacrolimus
Publications * Busque S, Leventhal J, Brennan DC, Steinberg S, Klintmalm G, Shah T, Mulgaonkar S, Bromberg JS, Vincenti F, Hariharan S, Slakey D, Peddi VR, Fisher RA, Lawendy N, Wang C, Chan G. Calcineurin-inhibitor-free immunosuppression based on the JAK inhibitor CP-690,550: a pilot study in de novo kidney allograft recipients. Am J Transplant. 2009 Aug;9(8):1936-45. doi: 10.1111/j.1600-6143.2009.02720.x.

*   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: November 12, 2012)
61
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE July 2006
Actual Primary Completion Date July 2006   (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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00106639
Other Study ID Numbers  ICMJE A3921009
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