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Completed

NCT Number: NCT01375127

Collection of Follow-up Data From CP-690,550-treated Kidney Transplant Recipients

This is an observational study designed to collect follow-up clinical date on subjects who were treated with tofacitinib in 2 completed Phase 2 studies who either discontinued treatment prematurely or did not elect to enroll in long-term extension studies.

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Key information

Conditions

Kidney Transplantation

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer Investigational Site, Camperdown, New South Wales, Australia

Loading trial locations.

About this study

Subjects are identified based on whether they received tofacitinib in 2 completed Phase 2 studies who either discontinued treatment prematurely or who did not elect to enroll in long-term extension studies. Subjects are pre-identified

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects have discontinued tofacitinib prior to the planned treatment duration in 2 completed Phase 2 studies; or have not enrolled in long-term extension studies.

Exclusion criteria

  • No other subjects are eligible for this study

Treatment and study plan

tofacitinib

Drug

Subjects who previously took 15 mg BID or 30 mg BID

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Number of Participants Who Died

    Time frame: Baseline through Month 12

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jun 17, 2011
Registry last updated
Oct 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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