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Extension Study Of Stage 1 Subjects Of Study A3921009 For The Prevention Of Acute Rejection In Kidney Transplant Patient

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
Multi Organ Transplant Center
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

- Enrollment in Stage 1 of Study A3921009 and have completed 6-months of treatment with
trial medications (CP-690,550 or tacrolimus)

- Recipient of a first-time kidney transplant

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

- Subject with any untreated condition that may affect drug absorption (eg, gastrectomy
or clinically significant diabetic gastroenteropathy).

- Subjects who are on the waiting list for a second kidney transplant or any non-renal
organ transplants.

NCT00263328
Pfizer
Completed
Extension Study Of Stage 1 Subjects Of Study A3921009 For The Prevention Of Acute Rejection In Kidney Transplant Patient

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Extension Study Of Stage 1 Subjects Of Study A3921009 For The Prevention Of Acute Rejection In Kidney Transplant Patient
A Multicenter, Phase 2, Open-label, Controlled, Extension Study For Stage 1 Subjects Of Study A3921009 To Evaluate The Long-term Safety And Efficacy Of Cp-690,550 Versus Tacrolimus, When Co-administered With Mycophenolate Mofetil In Renal Allograft Recipients
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 study A3921009, kidney transplant patients were given a JAK inhibitor or tacrolimus for 6 months posttransplant. Patients who completed study A3921009 were offered the opportunity to participate in study A3921021 which will extend the evaluation of safety and efficacy of CP-690,550 versus tacrolimus through 8 years posttransplant. In treatment group 1 (control arm), subjects will continue to receive tacrolimus. In treatment groups 2 and 3, subjects will continue to receive CP-690,550. Per Amendment 4, the tacrolimus comparator arm will be discontinued.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Kidney Transplantation
  • Drug: Tacrolimus
    Standard of care
  • Drug: CP-690,550
    CP-690,550 5 mg BID
  • Drug: CP-690,550
    CP-690,550 10 mg BID
  • Active Comparator: Treatment group 1
    Standard of care
    Intervention: Drug: Tacrolimus
  • Experimental: Treatment group 2
    Treatment group 2 also receives mycophenolate mofetil
    Intervention: Drug: CP-690,550
  • Experimental: Treatment group 3
    Treatment group 3 does not receive mycophenolate mofetil
    Intervention: Drug: CP-690,550
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
46
June 2014
January 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Enrollment in Stage 1 of Study A3921009 and have completed 6-months of treatment with trial medications (CP-690,550 or tacrolimus)
  • Recipient of a first-time kidney transplant

Exclusion Criteria:

  • Subject with any untreated condition that may affect drug absorption (eg, gastrectomy or clinically significant diabetic gastroenteropathy).
  • Subjects who are on the waiting list for a second kidney transplant or any non-renal organ transplants.
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
 
 
NCT00263328
A3921021
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2015

ICMJE     Data element required by the

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

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