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

An observational study of Kidney Transplantation, run by Pfizer at 43 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This 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. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Kidney Transplantation
What is being tested?: Tofacitinib
How many people: 83 participants
Where: 43 sitesin 12 countries
Study dates: Aug 2011to Jul 2012
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Subjects 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.

Who may be able to join

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.

Who cannot join

No other subjects are eligible for this study

Trial locations and contacts

43 sites in 12 countries.

Country

City, postcode or hospital

43 sites in 12 countries

United States23 sites

Pfizer Investigational Site
Ann Arbor, Michigan, 48109
Pfizer Investigational Site
Aurora, Colorado, 80045
Pfizer Investigational Site
Boston, Massachusetts, 02215
Pfizer Investigational Site
Chapel Hill, North Carolina, 27599-7211
Pfizer Investigational Site
Chicago, Illinois, 60611
Pfizer Investigational Site
Chicago, Illinois, 60637
Pfizer Investigational Site
Dallas, Texas, 75204
Pfizer Investigational Site
Dallas, Texas, 75246
Pfizer Investigational Site
Detroit, Michigan, 48202
Pfizer Investigational Site
Fort Worth, Texas, 76104
Pfizer Investigational Site
Livingston, New Jersey, 07039
Pfizer Investigational Site
Los Angeles, California, 90024
Pfizer Investigational Site
Los Angeles, California, 90095
Pfizer Investigational Site
New York, New York, 10029
Pfizer Investigational Site
Palo Alto, California, 94304
Pfizer Investigational Site
Richmond, Virginia, 23298
Pfizer Investigational Site
San Francisco, California, 94115
Pfizer Investigational Site
San Francisco, California, 94143
Pfizer Investigational Site
Springfiled, Massachusetts, 01107
Pfizer Investigational Site
St Louis, Missouri, 63110
Pfizer Investigational Site
Stanford, California, 94305
Pfizer Investigational Site
Tampa, Florida, 33606
Pfizer Investigational Site
Valhalla, New York, 10595

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Australia5 sites

Pfizer Investigational Site
Adelaide, South Australia, 5000
Pfizer Investigational Site
Camperdown, New South Wales, 2050
Pfizer Investigational Site
Clayton, Victoria, 3168
Pfizer Investigational Site
Parkville, Victoria, 3050
Pfizer Investigational Site
Westmead, New South Wales, 2145

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France3 sites

Pfizer Investigational Site
Nantes, 44093
Pfizer Investigational Site
Paris, 75743
Pfizer Investigational Site
Toulouse, 31059

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Brazil2 sites

Pfizer Investigational Site
Porto Alegre, Rio Grande do Sul, 90020-090
Pfizer Investigational Site
São Paulo, São Paulo, 04038-002

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Germany2 sites

Pfizer Investigational Site
Berlin, 10117
Pfizer Investigational Site
Hamburg, 20246

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Spain2 sites

Pfizer Investigational Site
Barcelona, Barcelona, 08036
Pfizer Investigational Site
L'Hospitalet de Llobregat, Barcelona, 08907

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Belgium1 site

Pfizer Investigational Site
Anderlecht, 1070

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Canada1 site

Pfizer Investigational Site
Edmonton, Alberta, T6G 2B7

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Czechia1 site

Pfizer Investigational Site
Praha 4 - Krc, 14021

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Italy1 site

Pfizer Investigational Site
Roma, 00168

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Netherlands1 site

Pfizer Investigational Site
Rotterdam, 3015 GD

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Norway1 site

Pfizer Investigational Site
Oslo, 0027

Other trials in Norway

About this study

Official title: An Observational Study To Collect Follow-up Clinical Data From Kidney Transplant Recipients Who Received Tofacitinib (CP-690,550) In Completed Phase 2 Studies

Read the detailed description

Subjects 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

Conditions: Kidney Transplantation
Being tested: Tofacitinib
Keywords: Observational, clinical follow-up data

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TofacitinibDrug
Subjects who previously took 15 mg BID or 30 mg BID
TofacitinibDrug
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 in NCT01375127
Study group	Role	What they receive
Subjects from Study A3921009		Not described Receives: Drug: Tofacitinib
Subjects from Study A3921030		Not described Receives: Drug: Tofacitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Clinical Outcome of Post Transplant Lymphoproliferative Disease (PTLD)
All lymphoproliferative disorders diagnosed locally as PTLD based on histopathology were reported.
Measured: Baseline through Month 12
Number of Participants With Central Nervous System (CNS) Infection
Participants with CNS infection involving the brain or spinal cord, within 12 months after the last dose of tofacitinib were reported.
Measured: Baseline through Month 12
Number of Participants With Graft Failure
Graft failure which occurred within 12 months after the last dose of tofacitinib was reported. Graft failure was defined as graft nephrectomy, re-transplantation, or return to dialysis for greater than or equal to (>=) 6 consecutive weeks.
Measured: Baseline through Month 12
Number of Participants Who Died
Measured: Baseline through Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2011Jul 2012

First posted17 Jun 2011 (estimated)
Study startAug 2011
Primary completionJul 2012
Study completionJul 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Kidney TransplantationStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Time perspective: Retrospective
Enrolment: 83 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01375127
Sponsor's protocol ID: A3921053
Status last verified: Sep 2013
First submitted: 13 Jun 2011
Last updated: 29 Oct 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
RecruitingPhase 2
A Study of Mezagitamab in Adults With Late Antibody-Mediated Rejection (AMR) After a Kidney Transplant
Antibody-Mediated Rejection (AMR)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruitingEarly Phase 1
Biomarker-Guided Mycophenolate Mofetil Elimination in Low-Risk Older Adult Kidney Transplant Recipients
Kidney Transplant Recipient
Recruiting
Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
Pediatric Kidney Disease, Transplant;Failure,Kidney

All Kidney Transplantation trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Observational Study To Collect Follow-up Clinical Data From Kidney Transplant Recipients Who Received Tofacitinib (CP-690,550) In Completed Phase 2 Studies
ClinicalTrials.gov ID: NCT01375127
Acronym / sponsor ID: A3921053
Conditions: Kidney Transplantation
Keywords: Observational, clinical follow-up data
Study type: Observational
Recruitment status: Completed
Enrolment: 83 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Aug 2011
Primary completion: Jul 2012 (actual)
Study completion: Jul 2012 (actual)
First posted: 17 Jun 2011 (estimated)
Results: Posted 14 Aug 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
Subjects from Study A3921009	–	Drug: Tofacitinib
Subjects from Study A3921030	–	Drug: Tofacitinib

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Subjects 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.

Key inclusion criteria (1 listed)

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.

Key exclusion criteria (1 listed)

No other subjects are eligible for this study

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TofacitinibSubjects who previously took 15 mg BID or 30 mg BID	Drug	Subjects from Study A3921009
TofacitinibSubjects who previously took 15 mg BID for 3 months then 10 mg BID, or 15 mg BID for 6 months then 10 mg BID	Drug	Subjects from Study A3921030

Primary outcome

Number of Participants With Clinical Outcome of Post Transplant Lymphoproliferative Disease (PTLD)
Time frame: Baseline through Month 12
All lymphoproliferative disorders diagnosed locally as PTLD based on histopathology were reported.
Number of Participants With Central Nervous System (CNS) Infection
Time frame: Baseline through Month 12
Participants with CNS infection involving the brain or spinal cord, within 12 months after the last dose of tofacitinib were reported.
Number of Participants With Graft Failure
Time frame: Baseline through Month 12
Graft failure which occurred within 12 months after the last dose of tofacitinib was reported. Graft failure was defined as graft nephrectomy, re-transplantation, or return to dialysis for greater than or equal to (>=) 6 consecutive weeks.
Number of Participants Who Died
Time frame: Baseline through Month 12

Results and safety

Results posted to the registry on 14 Aug 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tofacitinib 10 mg (Pre-amendment 1, Study A3921030)	1	1
Tofacitinib 15 mg (Pre-amendment 1, Study A3921030)	1	1
Tofacitinib 15 mg (Study A3921030, Month 1 to 6)	40	40
Tofacitinib 15 mg (Study A3921030, Month 1 to 3)	33	33
Tofacitinib 15 mg (Study A3921009)	5	5
Tofacitinib 30 mg (Study A3921009)	3	3

Primary outcome: Number of Participants With Clinical Outcome of Post Transplant Lymphoproliferative Disease (PTLD)

Time frame: Baseline through Month 12. Number. Unit: participants

Measure	Tofacitinib 10 mg (Pre-amendment 1, Study A3921030) n = 1	Tofacitinib 15 mg (Pre-amendment 1, Study A3921030) n = 1	Tofacitinib 15 mg (Study A3921030, Month 1 to 6) n = 40	Tofacitinib 15 mg (Study A3921030, Month 1 to 3) n = 33	Tofacitinib 15 mg (Study A3921009) n = 5	Tofacitinib 30 mg (Study A3921009) n = 3
Value	0	0	0	0	0	0

Population analysed: Safety analysis included all eligible participants who had provided an informed consent for this study.

Primary outcome: Number of Participants With Central Nervous System (CNS) Infection

Time frame: Baseline through Month 12. Number. Unit: participants

Measure	Tofacitinib 10 mg (Pre-amendment 1, Study A3921030) n = 1	Tofacitinib 15 mg (Pre-amendment 1, Study A3921030) n = 1	Tofacitinib 15 mg (Study A3921030, Month 1 to 6) n = 40	Tofacitinib 15 mg (Study A3921030, Month 1 to 3) n = 33	Tofacitinib 15 mg (Study A3921009) n = 5	Tofacitinib 30 mg (Study A3921009) n = 3
Value	0	0	0	0	0	0

Population analysed: Safety analysis included all eligible participants who had provided an informed consent for this study.

Primary outcome: Number of Participants With Graft Failure

Time frame: Baseline through Month 12. Number. Unit: participants

Measure	Tofacitinib 10 mg (Pre-amendment 1, Study A3921030) n = 1	Tofacitinib 15 mg (Pre-amendment 1, Study A3921030) n = 1	Tofacitinib 15 mg (Study A3921030, Month 1 to 6) n = 40	Tofacitinib 15 mg (Study A3921030, Month 1 to 3) n = 33	Tofacitinib 15 mg (Study A3921009) n = 5	Tofacitinib 30 mg (Study A3921009) n = 3
Value	0	0	2	3	0	0

Population analysed: Safety analysis included all eligible participants who had provided an informed consent for this study.

Primary outcome: Number of Participants Who Died

Time frame: Baseline through Month 12. Number. Unit: participants

Measure	Tofacitinib 10 mg (Pre-amendment 1, Study A3921030) n = 1	Tofacitinib 15 mg (Pre-amendment 1, Study A3921030) n = 1	Tofacitinib 15 mg (Study A3921030, Month 1 to 6) n = 40	Tofacitinib 15 mg (Study A3921030, Month 1 to 3) n = 33	Tofacitinib 15 mg (Study A3921009) n = 5	Tofacitinib 30 mg (Study A3921009) n = 3
Value	0	0	0	0	0	0

Population analysed: Safety analysis included all eligible participants who had provided an informed consent for this study.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tofacitinib 10 mg (Pre-amendment 1, Study A3921030)	0 of 1 (0%)	0 of 0	Not reported
Tofacitinib 15 mg (Pre-amendment 1, Study A3921030)	0 of 1 (0%)	0 of 0	Not reported
Tofacitinib 15 mg (Study A3921030, Month 1 to 6)	0 of 40 (0%)	0 of 0	Not reported
Tofacitinib 15 mg (Study A3921030, Month 1 to 3)	0 of 33 (0%)	0 of 0	Not reported
Tofacitinib 15 mg (Study A3921009)	0 of 5 (0%)	0 of 0	Not reported
Tofacitinib 30 mg (Study A3921009)	0 of 3 (0%)	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Kidney Transplantation

Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
RecruitingPhase 2
A Study of Mezagitamab in Adults With Late Antibody-Mediated Rejection (AMR) After a Kidney Transplant
Antibody-Mediated Rejection (AMR)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
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Not yet recruitingEarly Phase 1
Biomarker-Guided Mycophenolate Mofetil Elimination in Low-Risk Older Adult Kidney Transplant Recipients
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Recruiting
Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

43 sites in 12 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Kidney Transplantation, run by Pfizer at 43 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in United States, Australia, France, Brazil, Germany and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Clinical Outcome of Post Transplant Lymphoproliferative Disease (PTLD) (time frame: Baseline through Month 12). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01375127.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2013.