Collection of Follow-up Data From CP-690,550-treated Kidney Transplant Recipients
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|ClinicalTrials.gov Identifier: NCT01375127|
Recruitment Status : Completed
First Posted : June 17, 2011
Results First Posted : August 14, 2013
Last Update Posted : October 29, 2013
|Condition or disease||Intervention/treatment|
|Kidney Transplantation||Drug: Tofacitinib|
|Study Type :||Observational|
|Actual Enrollment :||83 participants|
|Official Title:||An Observational Study To Collect Follow-up Clinical Data From Kidney Transplant Recipients Who Received Tofacitinib (CP-690,550) In Completed Phase 2 Studies|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||July 2012|
|Subjects from Study A3921009||
Subjects who previously took 15 mg BID or 30 mg BID
|Subjects from Study A3921030||
Subjects who previously took 15 mg BID for 3 months then 10 mg BID, or 15 mg BID for 6 months then 10 mg BID
- Number of Participants With Clinical Outcome of Post Transplant Lymphoproliferative Disease (PTLD) [ Time Frame: Baseline through Month 12 ]All lymphoproliferative disorders diagnosed locally as PTLD based on histopathology were reported.
- Number of Participants With Central Nervous System (CNS) Infection [ Time Frame: Baseline through Month 12 ]Participants with CNS infection involving the brain or spinal cord, within 12 months after the last dose of tofacitinib were reported.
- Number of Participants With Graft Failure [ Time Frame: Baseline through Month 12 ]Graft failure which occurred within 12 months after the last dose of tofacitinib was reported. Graft failure was defined as graft nephrectomy, re-transplantation, or return to dialysis for greater than or equal to (>=) 6 consecutive weeks.
- Number of Participants Who Died [ Time Frame: Baseline through Month 12 ]
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01375127
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|Study Director:||Pfizer CT.gov Call Center||Pfizer|