A study to collect follow up clinical data in kidney transplant subjects from two completed studies.

Conditions: KIDNEY TRANSPLANT
MedDRA version: 14.0Level: LLTClassification code 10023438Term: Kidney transplantSystem Organ Class: 10042613 - Surgical and medical procedures
Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Registration Number: EUCTR2011-000903-41-DE

Lead Sponsor: Pfizer Inc.235 East 42nd Street, New York, NY 10017, USA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 110

Inclusion Criteria

Subjects must meet all of the following criteria to be eligible for enrollment into the trial:
1. Subject must meet at least 1 of the following 2 criteria:

a. Subjects have discontinued tofacitinib prior to the planned treatment duration of study A3921009 (6 months posttransplant) or study A3921030 (12 months posttransplant); or

b. Subjects have not enrolled in the extension studies A3921021 or A3921050.

2. Subjects must be willing and able to provide written informed consent with evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all the pertinent
aspects of the study.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 94
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 16

Exclusion Criteria

Not applicable

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: Not applicable;Primary end point(s): The endpoints are the clinical outcome measures occurring within 12 months after discontinuation of tofacitinib.;Timepoint(s) of evaluation of this end point: non applicable;Main Objective: The primary objective of this study is to evaluate the clinical outcomes of eligible subjects through 12 months after discontinuation of tofacitinib.

Secondary Outcome Measures