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

Last updated on December 4, 2019

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Study Location
Pfizer Investigational Site
Los Angeles, California, 90024 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Kidney Transplantation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- No other subjects are eligible for this study

NCT01375127
Pfizer
Completed
Collection of Follow-up Data From CP-690,550-treated Kidney Transplant Recipients

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Descriptive Information
Brief TitleCollection of Follow-up Data From CP-690,550-treated Kidney Transplant Recipients
Official TitleAn Observational Study To Collect Follow-up Clinical Data From Kidney Transplant Recipients Who Received Tofacitinib (CP-690,550) In Completed Phase 2 Studies
Brief SummaryThis 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.
Detailed DescriptionSubjects 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
Study TypeObservational
Study DesignTime Perspective: Retrospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodProbability Sample
Study PopulationSubjects who received treatment with tofacitinib in 2 completed Phase 2 studies who either discontinued treatment prematurely or who did not elect to enroll in long-term extension studies.
ConditionKidney Transplantation
Intervention
  • Drug: Tofacitinib
    Subjects who previously took 15 mg BID or 30 mg BID
  • Drug: 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
Study Groups/Cohorts
  • Subjects from Study A3921009
    Intervention: Drug: Tofacitinib
  • Subjects from Study A3921030
    Intervention: Drug: Tofacitinib
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment StatusCompleted
Actual Enrollment
 (submitted: May 17, 2013)
83
Original Estimated Enrollment
 (submitted: June 16, 2011)
110
Actual Study Completion DateJuly 2012
Actual Primary Completion DateJuly 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study:All
Ages18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesAustralia,   Belgium,   Brazil,   Canada,   Czech Republic,   France,   Germany,   Italy,   Netherlands,   Norway,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT NumberNCT01375127
Other Study ID NumbersA3921053
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateSeptember 2013

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]

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