A study to collect follow up clinical data in kidney transplant subjects from two completed studies.
- Conditions
- KIDNEY TRANSPLANTMedDRA version: 14.1Level: LLTClassification code 10023438Term: Kidney transplantSystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic 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
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
Not applicable.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method