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Study of 2 Dose Levels of a JAK3 Inhibitor for the Prevention of Acute Rejection in Kidney Transplant Patients

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00106639
First received: March 28, 2005
Last updated: October 12, 2006
Last verified: October 2006
History of Changes

March 28, 2005
October 12, 2006
May 2005
 
Biopsy Proven Acute Rejection rate at 6 months Glomerular Filtration rate at 6 months
Same as current
Complete list of historical versions of study NCT00106639 on ClinicalTrials.gov Archive Site
 
 
 
 
 
Study of 2 Dose Levels of a JAK3 Inhibitor for the Prevention of Acute Rejection 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

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 tacrolimus will be given to new kidney transplant patients for 6 months. Patients who respond well will be offered the opportunity to participate in an additional study to receive the JAK3 inhibitor or tacrolimus long-term. There will be 2 stages of enrollment in this study. In both stages of this research study, patients will be assigned to one of three treatment groups from the day after receiving a kidney transplant. Two of the treatment groups will be 2 different dose levels of the JAK3 inhibitor that will be taken by mouth. The third treatment group will be twice daily tacrolimus (Prograf). Patients will continue to take the assigned study medication (JAK3 inhibitor or tacrolimus) for 6 months as well as other standard transplant medications such as Cellcept and prednisone.
 
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Kidney Transplantation
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
249
July 2006
 

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00106639
A3921009
 
 
Pfizer
 
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2006

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