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|
|Primary Completion Date :||July 2012|
|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|