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

AN OBSERVATIONAL STUDY TO COLLECT FOLLOW-UP CLINICAL DATA FROM KIDNEY TRANSPLANT RECIPIENTS WHO RECEIVED TOFACITINIB (CP-690,550) IN COMPLETED PHASE 2 STUDIES

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-000903-41-ES

Enrollment

110

Registered

2011-07-21

Start date

2011-10-24

Completion date

Unknown

Last updated

2012-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

KIDNEY TRANSPLANT MedDRA version: 14.0 Level: LLT Classification code 10023438 Term: Kidney transplant System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Product Name: CP-690,550 Pharmaceutical Form: Tablet INN or Proposed INN: Tofacitinib (Proposed) CAS Number: 540737-29-9 Current Sponsor code: CP-690,550-10 Other descriptive name: (3R,4R)-4-methyl-3-

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: Not applicable

Design outcomes

Primary

Measure	Time frame
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 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	—

Secondary

Measure	Time frame
Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: non applicable	—

Countries

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

Contacts

Public ContactClinical Trials.gov Call Center

Pfizer Inc

clinicaltrials.govcallcentre@pfizer.com0018007181021

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026