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

Conditions
KIDNEY TRANSPLANT
MedDRA version: 14.1Level: 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-IT
Lead Sponsor
PFIZER INC.
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
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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