Randomized phase 2b trial of tofacitinib (CP-690,550) in de novo kidney transplant patients: Efficacy, renal function and safety at 1 year

F. Vincenti*, H. Tedesco Silva, S. Busque, P. O'Connell, J. Friedewald, D. Cibrik, K. Budde, A. Yoshida, S. Cohney, W. Weimar, Y. S. Kim, N. Lawendy, S. P. Lan, E. Kudlacz, S. Krishnaswami, G. Chan

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

109 Scopus citations


In this Phase 2b study, 331 low-to-moderate risk de novo kidney transplant patients (approximately 60% deceased donors) were randomized to a more intensive (MI) or less intensive (LI) regimen of tofacitinib (CP-690, 550), an oral Janus kinase inhibitor or cyclosporine (CsA). All patients received basiliximab induction, mycophenolic acid and corticosteroids. Primary endpoints were: incidence of biopsy-proven acute rejection (BPAR) with a serum creatinine increase of >0.3 mg/dL and >20% (clinical BPAR) at Month 6 and measured GFR at Month 12. Similar 6-month incidences of clinical BPAR (11%, 7% and 9%) were observed for MI, LI and CsA. Measured GFRs were higher (p < 0.01) at Month 12 for MI and LI versus CsA (65 mL/min, 65 mL/min vs. 54 mL/min). Fewer (p < 0.05) patients in MI or LI developed chronic allograft nephropathy at Month 12 compared with CsA (25%, 24% vs. 48%). Serious infections developed in 45%, 37% and 25% of patients in MI, LI and CsA, respectively. Anemia, neutropenia and posttransplant lymphoproliferative disorder occurred more frequently in MI and LI compared with CsA. Tofacitinib was equivalent to CsA in preventing acute rejection, was associated with improved renal function and less chronic allograft histological injury, but had side-effects at the doses evaluated. The authors present the results of a phase 2b trial of tofacitinib in renal transplantation.

Original languageEnglish (US)
Pages (from-to)2446-2456
Number of pages11
JournalAmerican Journal of Transplantation
Issue number9
StatePublished - Sep 2012


  • cyclosporine
  • kidney
  • renal function
  • tofacitinib

ASJC Scopus subject areas

  • Immunology and Allergy
  • Transplantation
  • Pharmacology (medical)


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