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

Kidney Transplantation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01375127
• Other study ID #: A3921053
• Status: Completed
• Phase: N/A
• First received: June 13, 2011
• Last updated: September 25, 2013
• Start date: August 2011
• Est. completion date: July 2012

Study information

• Verified date: September 2013
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

Drug:
• Tofacitinib
Subjects who previously took 15 mg BID or 30 mg BID
• Tofacitinib
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

Locations

Country	Name	City	State
Australia	Pfizer Investigational Site	Adelaide	South Australia
Australia	Pfizer Investigational Site	Camperdown	New South Wales
Australia	Pfizer Investigational Site	Clayton	Victoria
Australia	Pfizer Investigational Site	Parkville	Victoria
Australia	Pfizer Investigational Site	Westmead	New South Wales
Belgium	Pfizer Investigational Site	Anderlecht
Brazil	Pfizer Investigational Site	Porto Alegre	RS
Brazil	Pfizer Investigational Site	Sao Paulo	SP
Canada	Pfizer Investigational Site	Edmonton	Alberta
Czech Republic	Pfizer Investigational Site	Praha 4 - Krc
France	Pfizer Investigational Site	Nantes Cedex 1
France	Pfizer Investigational Site	Paris Cedex 15
France	Pfizer Investigational Site	Toulouse Cedex 9
Germany	Pfizer Investigational Site	Berlin
Germany	Pfizer Investigational Site	Hamburg
Italy	Pfizer Investigational Site	Roma
Netherlands	Pfizer Investigational Site	Rotterdam
Norway	Pfizer Investigational Site	Oslo
Spain	Pfizer Investigational Site	Barcelona
Spain	Pfizer Investigational Site	L'Hospitalet de Llobregat	Barcelona
United States	Pfizer Investigational Site	Ann Arbor	Michigan
United States	Pfizer Investigational Site	Aurora	Colorado
United States	Pfizer Investigational Site	Boston	Massachusetts
United States	Pfizer Investigational Site	Chapel Hill	North Carolina
United States	Pfizer Investigational Site	Chicago	Illinois
United States	Pfizer Investigational Site	Chicago	Illinois
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Detroit	Michigan
United States	Pfizer Investigational Site	Fort Worth	Texas
United States	Pfizer Investigational Site	Livingston	New Jersey
United States	Pfizer Investigational Site	Los Angeles	California
United States	Pfizer Investigational Site	Los Angeles	California
United States	Pfizer Investigational Site	New York	New York
United States	Pfizer Investigational Site	Palo Alto	California
United States	Pfizer Investigational Site	Richmond	Virginia
United States	Pfizer Investigational Site	San Francisco	California
United States	Pfizer Investigational Site	San Francisco	California
United States	Pfizer Investigational Site	Springfiled	Massachusetts
United States	Pfizer Investigational Site	St. Louis	Missouri
United States	Pfizer Investigational Site	Stanford	California
United States	Pfizer Investigational Site	Tampa	Florida
United States	Pfizer Investigational Site	Valhalla	New York

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Brazil,  Canada,  Czech Republic,  France,  Germany,  Italy,  Netherlands,  Norway,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Clinical Outcome of Post Transplant Lymphoproliferative Disease (PTLD)	All lymphoproliferative disorders diagnosed locally as PTLD based on histopathology were reported.	Baseline through Month 12	Yes
Primary	Number of Participants With Central Nervous System (CNS) Infection	Participants with CNS infection involving the brain or spinal cord, within 12 months after the last dose of tofacitinib were reported.	Baseline through Month 12	Yes
Primary	Number of Participants With Graft Failure	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.	Baseline through Month 12	Yes
Primary	Number of Participants Who Died		Baseline through Month 12	Yes

External Links

•   To obtain contact information for a study center near you, click here.