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

Last updated on August 9, 2018

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

NCT00106639
Pfizer
Completed
A 6-Month Study Of CP-690,550 Versus Tacrolimus In Kidney Transplant Patients

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A 6-Month Study Of CP-690,550 Versus Tacrolimus In Kidney Transplant Patients
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Kidney Transplantation
  • Drug: CP-690,550
    15 mg twice daily
  • Drug: CP-690,550
    30 mg twice daily
  • Drug: tacrolimus
    dose adjusted according to level
  • 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
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.
 
Completed
61
July 2006
July 2006   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00106639
A3921009
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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