Kidney TransplantPhase 1NCT01710033

A Study Of CP-690,550 In Stable Kidney Transplant Patients

A Phase 1 study testing CP-690,550 5 mg BID, CP-690,550 15 mg BID and CP-690,550 30 mg BID in people with Kidney Transplant, run by Pfizer at 11 sites in 2 countries.

Completed

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

Official record

Search all trials

Trial summary

This was a Phase 1 dose escalation study to evaluate the safety, tolerability and pharmacokinetics of 28-day treatment of CP-690,550 in stable renal allograft recipients. In Stage 1, ascending doses of CP-690,550 were to be administered sequentially to 3-4 cohorts of subjects. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Kidney Transplant
What is being tested?: CP-690,550 5 mg BID, CP-690,550 15 mg BID and CP-690,550 30 mg BID
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 28 participants
Where: 11 sitesin 2 countries
Study dates: Sep 2003to Apr 2005
Phase: Phase 1
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

Who may be able to join

Medically stable kidney transplant patients 6 or more months after transplantation.
Subjects must be on mycophenolate mofetil 1-2 gm daily
In Cohort 3 (and 4, if conducted) in Stage 1 and the expanded cohort in Stage 2, subjects must be on a calcineurin inhibitor-free regimen.

Who cannot join

Any rejection episodes in the preceding 3 months.
Treated with Thymoglobulin or OKT3 for acute rejection in the past 6 months.

Trial locations and contacts

11 sites in 2 countries.

Country

City, postcode or hospital

11 sites in 2 countries

United States10 sites

Pfizer Investigational Site
Birmingham, Alabama, 35249-6860
Pfizer Investigational Site
Birmingham, Alabama, 35249
Pfizer Investigational Site
Birmingham, Alabama, 35294-6862
Pfizer Investigational Site
Indianapolis, Indiana, 46202
Pfizer Investigational Site
Livingston, New Jersey, 07039
Pfizer Investigational Site
Los Angeles, California, 90057
Pfizer Investigational Site
Madison, Wisconsin, 53792
Pfizer Investigational Site
Minneapolis, Minnesota, 55404
Pfizer Investigational Site
St Louis, Missouri, 63110-1092
Pfizer Investigational Site
St Louis, Missouri, 63110-1093

Other trials in United States

Location not given1 site

Pfizer Investigational Site

About this study

Official title: Phase 1, Placebo-controlled, Randomized, Sequential, Parallel-group, Dose Escalation Study to Evaluate 28-day Multiple Dose Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CP-690,550 in Stable Renal Allograft Recipients

Conditions: Kidney Transplant
Being tested: Placebo, CP-690,550 5 mg BID, CP-690,550 15 mg BID, CP-690,550 30 mg BID
Keywords: CP-690,550, kidney transplant

What participants receive

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

PlaceboDrug
Placebo tables twice daily (BID) for 28 days
CP-690,550 5 mg BIDDrug
CP-690,550 5 mg BID for 28 days
CP-690,550 15 mg BIDDrug
CP-690,550 15 mg BID for 28 days
CP-690,550 30 mg BIDDrug
CP-690,550 30 mg BID for 28 days

Study groups in NCT01710033
Study group	Role	What they receive
Placebo	Placebo comparator	Not described Receives: Drug: Placebo
CP-690,550 5 mg BID	Experimental	Not described Receives: Drug: CP-690,550 5 mg BID
CP-690,550 15 mg BID	Experimental	Not described Receives: Drug: CP-690,550 15 mg BID
CP-690,550 30 mg BID	Experimental	Not described Receives: Drug: CP-690,550 30 mg BID

What is being measured

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

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) For CP-690,550
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).
Measured: 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) at Steady State For CP-690,550
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) at steady state.
Measured: 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29
Area Under the Curve From Time Zero to 12 Hour Concentration [AUC(0-12)] at Steady State For CP-690,550
Area under the plasma concentration time-curve from zero to 12 hour concentration [AUC(0-12)] at steady state.
Measured: 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 29
Maximum Observed Plasma Concentration (Cmax) For CP-690,550
Measured: 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1
Maximum Observed Plasma Concentration (Cmax) at Steady State For CP-690,550
Measured: 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29
Time to Reach Maximum Observed Plasma Concentration (Tmax) For CP-690,550
Measured: 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1
Time to Reach Maximum Observed Plasma Concentration (Tmax) at Steady State For CP-690,550
Measured: 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29
Accumulation Ratio (Rac) For CP-690,550
Rac obtained from AUC(0-12) (Day 29) divided by AUC(0-12) (Day 1).
Measured: 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1 and 29
Plasma Decay Half-Life (t1/2) For CP-690,550
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Measured: 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1
Plasma Decay Half-Life (t1/2) at Steady State For CP-690,550
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half at steady state.
Measured: 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29
Mycophenolic Acid (MPA) Plasma Trough Concentration at Baseline
Pro-drug MMF was metabolically converted to active form MPA in the liver. The baseline for MPA trough concentrations was defined as the average of the values obtained at Screening and on Day 1 (pre-dose). MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure.
Measured: Screening, 0 hour (pre-dose) on Day 1
Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 8
Pro-drug MMF was metabolically converted to active form MPA in the liver. MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure.
Measured: 0 hour (pre-dose) on Day 8
Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 15
Pro-drug MMF was metabolically converted to active form MPA in the liver. MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure.
Measured: 0 hour (pre-dose) on Day 15
Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 29
Pro-drug MMF was metabolically converted to active form MPA in the liver. MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure.
Measured: 0 hour (pre-dose) on Day 29
Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 57
Pro-drug MMF was metabolically converted to active form MPA in the liver. MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure.
Measured: 0 hour (pre-dose) on Day 57
Cyclosporine (CsA) Plasma Trough Concentration at Baseline
The baseline for CsA trough concentrations was defined as the average of the values obtained at Screening and on Day 1 (pre-dose). CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure.
Measured: Screening, 0 hour (pre-dose) on Day 1
Cyclosporine (CsA) Plasma Trough Concentration at Day 8
CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure.
Measured: 0 hour (pre-dose) on Day 8
Cyclosporine (CsA) Plasma Trough Concentration at Day 15
CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure.
Measured: 0 hour (pre-dose) on Day 15
Cyclosporine (CsA) Plasma Trough Concentration at Day 29
CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure.
Measured: 0 hour (pre-dose) on Day 29
Cyclosporine (CsA) Plasma Trough Concentration at Day 57
CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure.
Measured: 0 hour (pre-dose) on Day 57
Tacrolimus (TAC) Plasma Trough Concentration at Baseline
The baseline for TAC trough concentrations was defined as the average of the values obtained at Screening and on Day 1 (pre-dose). TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure.
Measured: Screening, 0 hour (pre-dose) on Day 1
Tacrolimus (TAC) Plasma Trough Concentration at Day 8
TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure.
Measured: 0 hour (pre-dose) on Day 8
Tacrolimus (TAC) Plasma Trough Concentration at Day 15
TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure.
Measured: 0 hour (pre-dose) on Day 15
Tacrolimus (TAC) Plasma Trough Concentration at Day 29
TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure.
Measured: 0 hour (pre-dose) on Day 29
Tacrolimus (TAC) Plasma Trough Concentration at Day 57
TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure.
Measured: 0 hour (pre-dose) on Day 57

Timeline

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

Sep 2003Apr 2005

First posted18 Oct 2012 (estimated)
Study startSep 2003
Primary completionApr 2005
Study completionApr 2005

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 TransplantStudies 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: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01710033
Sponsor's protocol ID: A3921007
Status last verified: Nov 2012
First submitted: 16 Oct 2012
Last updated: 26 Dec 2012
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
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All Kidney Transplant trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 1, Placebo-controlled, Randomized, Sequential, Parallel-group, Dose Escalation Study to Evaluate 28-day Multiple Dose Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CP-690,550 in Stable Renal Allograft Recipients
ClinicalTrials.gov ID: NCT01710033
Acronym / sponsor ID: A3921007
Conditions: Kidney Transplant
Keywords: CP-690,550, kidney transplant
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Sep 2003
Primary completion: Apr 2005 (actual)
Study completion: Apr 2005 (actual)
First posted: 18 Oct 2012 (estimated)
Results: Posted 26 Dec 2012

Clinical summary

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

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Placebo	Placebo comparator	Drug: Placebo
CP-690,550 5 mg BID	Experimental	Drug: CP-690,550 5 mg BID
CP-690,550 15 mg BID	Experimental	Drug: CP-690,550 15 mg BID
CP-690,550 30 mg BID	Experimental	Drug: CP-690,550 30 mg BID

Who may qualify

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

Key inclusion criteria (3 listed)

Medically stable kidney transplant patients 6 or more months after transplantation.
Subjects must be on mycophenolate mofetil 1-2 gm daily
In Cohort 3 (and 4, if conducted) in Stage 1 and the expanded cohort in Stage 2, subjects must be on a calcineurin inhibitor-free regimen.

Key exclusion criteria (2 listed)

Any rejection episodes in the preceding 3 months.
Treated with Thymoglobulin or OKT3 for acute rejection in the past 6 months.

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
PlaceboPlacebo tables twice daily (BID) for 28 days	Drug	Placebo
CP-690,550 5 mg BIDCP-690,550 5 mg BID for 28 days	Drug	CP-690,550 5 mg BID
CP-690,550 15 mg BIDCP-690,550 15 mg BID for 28 days	Drug	CP-690,550 15 mg BID
CP-690,550 30 mg BIDCP-690,550 30 mg BID for 28 days	Drug	CP-690,550 30 mg BID

Primary outcome

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) For CP-690,550
Time frame: 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) at Steady State For CP-690,550
Time frame: 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) at steady state.
Area Under the Curve From Time Zero to 12 Hour Concentration [AUC(0-12)] at Steady State For CP-690,550
Time frame: 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 29
Area under the plasma concentration time-curve from zero to 12 hour concentration [AUC(0-12)] at steady state.
Maximum Observed Plasma Concentration (Cmax) For CP-690,550
Time frame: 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1
Maximum Observed Plasma Concentration (Cmax) at Steady State For CP-690,550
Time frame: 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29
Time to Reach Maximum Observed Plasma Concentration (Tmax) For CP-690,550
Time frame: 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1
Time to Reach Maximum Observed Plasma Concentration (Tmax) at Steady State For CP-690,550
Time frame: 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29
Accumulation Ratio (Rac) For CP-690,550
Time frame: 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1 and 29
Rac obtained from AUC(0-12) (Day 29) divided by AUC(0-12) (Day 1).
Plasma Decay Half-Life (t1/2) For CP-690,550
Time frame: 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Plasma Decay Half-Life (t1/2) at Steady State For CP-690,550
Time frame: 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half at steady state.
Mycophenolic Acid (MPA) Plasma Trough Concentration at Baseline
Time frame: Screening, 0 hour (pre-dose) on Day 1
Pro-drug MMF was metabolically converted to active form MPA in the liver. The baseline for MPA trough concentrations was defined as the average of the values obtained at Screening and on Day 1 (pre-dose). MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure.
Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 8
Time frame: 0 hour (pre-dose) on Day 8
Pro-drug MMF was metabolically converted to active form MPA in the liver. MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure.
Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 15
Time frame: 0 hour (pre-dose) on Day 15
Pro-drug MMF was metabolically converted to active form MPA in the liver. MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure.
Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 29
Time frame: 0 hour (pre-dose) on Day 29
Pro-drug MMF was metabolically converted to active form MPA in the liver. MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure.
Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 57
Time frame: 0 hour (pre-dose) on Day 57
Pro-drug MMF was metabolically converted to active form MPA in the liver. MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure.
Cyclosporine (CsA) Plasma Trough Concentration at Baseline
Time frame: Screening, 0 hour (pre-dose) on Day 1
The baseline for CsA trough concentrations was defined as the average of the values obtained at Screening and on Day 1 (pre-dose). CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure.
Cyclosporine (CsA) Plasma Trough Concentration at Day 8
Time frame: 0 hour (pre-dose) on Day 8
CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure.
Cyclosporine (CsA) Plasma Trough Concentration at Day 15
Time frame: 0 hour (pre-dose) on Day 15
CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure.
Cyclosporine (CsA) Plasma Trough Concentration at Day 29
Time frame: 0 hour (pre-dose) on Day 29
CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure.
Cyclosporine (CsA) Plasma Trough Concentration at Day 57
Time frame: 0 hour (pre-dose) on Day 57
CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure.
Tacrolimus (TAC) Plasma Trough Concentration at Baseline
Time frame: Screening, 0 hour (pre-dose) on Day 1
The baseline for TAC trough concentrations was defined as the average of the values obtained at Screening and on Day 1 (pre-dose). TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure.
Tacrolimus (TAC) Plasma Trough Concentration at Day 8
Time frame: 0 hour (pre-dose) on Day 8
TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure.
Tacrolimus (TAC) Plasma Trough Concentration at Day 15
Time frame: 0 hour (pre-dose) on Day 15
TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure.
Tacrolimus (TAC) Plasma Trough Concentration at Day 29
Time frame: 0 hour (pre-dose) on Day 29
TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure.
Tacrolimus (TAC) Plasma Trough Concentration at Day 57
Time frame: 0 hour (pre-dose) on Day 57
TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure.

Results and safety

Results posted to the registry on 26 Dec 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo, Stage 1	6	6
CP-690,550 5 mg, Stage 1	6	6
CP-690,550 15 mg, Stage 1	6	6
CP-690,550 30 mg, Stage 1	6	6
CP-690,550 30 mg, Stage 2	0	0

Primary outcome: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) For CP-690,550

Time frame: 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1. Mean (Standard Deviation). Unit: nanogram*hour per milliliter (ng*hr/mL)

Measure	CP-690,550 5 mg, Stage 1 n = 6	CP-690,550 15 mg, Stage 1 n = 6	CP-690,550 30 mg, Stage 1 And 2 n = 8
Value	183 (75.3)	754 (182)	1200 (266)

Population analysed: Analysis population included all randomized participants who received at least 1 dose of study treatment. Here "N" (Number of Participants Analyzed) signifies participants who were evaluable for this measure.

Primary outcome: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) at Steady State For CP-690,550

Time frame: 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29. Mean (Standard Deviation). Unit: ng*hr/mL

Measure	CP-690,550 5 mg, Stage 1 n = 6	CP-690,550 15 mg, Stage 1 n = 6	CP-690,550 30 mg, Stage 1 And 2 n = 9
Value	319 (175)	1300 (241)	1560 (311)

Primary outcome: Area Under the Curve From Time Zero to 12 Hour Concentration [AUC(0-12)] at Steady State For CP-690,550

Time frame: 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 29. Mean (Standard Deviation). Unit: ng*hr/mL

Measure	CP-690,550 5 mg, Stage 1 n = 6	CP-690,550 15 mg, Stage 1 n = 5	CP-690,550 30 mg, Stage 1 And 2 n = 9
Value	273 (132)	1090 (150)	1420 (253)

Primary outcome: Maximum Observed Plasma Concentration (Cmax) For CP-690,550

Time frame: 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1. Mean (Standard Deviation). Unit: nanogram per milliliter (ng/mL)

Measure	CP-690,550 5 mg, Stage 1 n = 6	CP-690,550 15 mg, Stage 1 n = 6	CP-690,550 30 mg, Stage 1 And 2 n = 8
Value	41.0 (14.9)	140 (34.5)	325 (113)

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo, Stage 1	1 of 6 (16.7%)	5 of 6 (83.3%)	Not reported
CP-690,550 5 mg, Stage 1	0 of 6 (0%)	5 of 6 (83.3%)	Not reported
CP-690,550 15 mg, Stage 1	2 of 6 (33.3%)	5 of 6 (83.3%)	Not reported
CP-690,550 30 mg, Stage 1 And 2	1 of 10 (10%)	8 of 10 (80%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2012.
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.

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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

11 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CP-690,550 5 mg BID, CP-690,550 15 mg BID and CP-690,550 30 mg BID in people with Kidney Transplant, run by Pfizer at 11 sites in 2 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 3 inclusion and 2 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 26 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Dec 2012). 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?

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) For CP-690,550 (time frame: 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1). The study lists 25 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 NCT01710033.

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 26 Dec 2012.