Renal ImpairmentPhase 1NCT01740362

Pharmacokinetics Of CP-690,550 In Patients With Impaired Renal Function

A Phase 1 study testing CP-690,550 in people with Renal Impairment, run by Pfizer at 4 sites in United States.

Completed

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

Trial summary

A study to evaluate the pharmacokinetics of CP-690,550 in subjects with mild, moderate or severe renal impairment, who do not require hemodialysis, compared to healthy controls. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Renal Impairment
What is being tested?: CP-690,550
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 4 sitesUnited States
Study dates: Oct 2003to Mar 2004
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 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Subjects with normal renal function: Subjects must be healthy with estimated creatinine clearance >80 mL/min
Subjects with renal impairment: Subjects should be in good general health commensurate with the population with chronic kidney disease

Who cannot join

Kidney transplant patients
Subjects with any condition possibly affecting drug absorption
Subjects with malignancies with the exception of adequately treated basal cell carcinoma of the skin

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Pfizer Investigational Site
Minneapolis, Minnesota, 55404
Pfizer Investigational Site
New Orleans, Louisiana, 70118
Pfizer Investigational Site
New Orleans, Louisiana, 70119
Pfizer Investigational Site
Orlando, Florida, 32806

Other trials in United States

About this study

Official title: Phase 1, Open-Label Study To Evaluate Single Dose Pharmacokinetics, Safety And Tolerability Of CP-690,550 In Patients With Impaired Renal Function

A study to evaluate the pharmacokinetics of CP-690,550 in subjects with mild, moderate or severe renal impairment, who do not require hemodialysis, compared to healthy controls.

Conditions: Renal Impairment
Being tested: CP-690,550
Keywords: CP-690, 550, pharmacokinetics, renal impairment
Medical subject headings: Renal Insufficiency

What participants receive

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

CP-690,550Drug
10 mg (2 x 5 mg tablets), single dose
CP-690,550Drug
10 mg (2 x 5 mg tablets), single dose
CP-690,550Drug
10 mg (2 x 5 mg tablets), single dose
CP-690,550Drug
10 mg (2 x 5 mg tablets), single dose

Study groups in NCT01740362
Study group	Role	What they receive
Healthy volunteers	Other	Healthy volunteers Receives: Drug: CP-690,550
Mild renal impairment	Experimental	patients with mild (>50 and ≤80 mL/min) renal impairment Receives: Drug: CP-690,550
Moderate renal impairment	Experimental	patients with moderate (≥30 and ≤50 mL/min) renal impairment Receives: Drug: CP-690,550
severe renal impairment	Experimental	patients with severe (<30 mL/min) renal impairment Receives: Drug: CP-690,550

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 Extrapolated Infinite Time [AUC (0 - ∞)]
AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
Measured: 0 (Pre-dose), 0.5, 1, 1.5, 2, 4, 8, 10, 12, 16, 24, 48 hours post-dose
Maximum Observed Plasma Concentration (Cmax)
Measured: 0 (Pre-dose), 0.5, 1, 1.5, 2, 4, 8, 10, 12, 16, 24, 48 hours post-dose
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Measured: 0 (Pre-dose), 0.5, 1, 1.5, 2, 4, 8, 10, 12, 16, 24, 48 hours post-dose
Plasma Decay Half-Life (t1/2)
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Measured: 0 (Pre-dose), 0.5, 1, 1.5, 2, 4, 8, 10, 12, 16, 24, 48 hours post-dose
Renal Clearance (CL R)
Renal clearance is the volume of plasma from which the drug is completely removed by the kidney in a given amount of time.
Measured: 0 (Pre-dose) to 12 hours post-dose, 12 to 24 hours post-dose

Timeline

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

Oct 2003Mar 2004

First posted4 Dec 2012 (estimated)
Study startOct 2003
Primary completionMar 2004
Study completionMar 2004

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Renal ImpairmentStudies 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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01740362
Sponsor's protocol ID: A3921006
Status last verified: Dec 2012
First submitted: 16 Oct 2012
Last updated: 7 Jan 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Krishnaswami S, Chow V, Boy M, Wang C, Chan G. Pharmacokinetics of tofacitinib, a janus kinase inhibitor, in patients with impaired renal function and end-stage renal disease. J Clin Pharmacol. 2014 Jan;54(1):46-52. doi: 10.1002/jcph.178. Epub 2013 Sep 30.
PubMed 24030917

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

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All Renal Impairment trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 1, Open-Label Study To Evaluate Single Dose Pharmacokinetics, Safety And Tolerability Of CP-690,550 In Patients With Impaired Renal Function
ClinicalTrials.gov ID: NCT01740362
Acronym / sponsor ID: A3921006
Conditions: Renal Impairment
Keywords: CP-690, 550, pharmacokinetics, renal impairment
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Oct 2003
Primary completion: Mar 2004 (actual)
Study completion: Mar 2004 (actual)
First posted: 4 Dec 2012 (estimated)
Results: Posted 7 Jan 2013

Clinical summary

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

A study to evaluate the pharmacokinetics of CP-690,550 in subjects with mild, moderate or severe renal impairment, who do not require hemodialysis, compared to healthy controls.

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Healthy volunteers	Other	Drug: CP-690,550Healthy volunteers
Mild renal impairment	Experimental	Drug: CP-690,550patients with mild (>50 and ≤80 mL/min) renal impairment
Moderate renal impairment	Experimental	Drug: CP-690,550patients with moderate (≥30 and ≤50 mL/min) renal impairment
severe renal impairment	Experimental	Drug: CP-690,550patients with severe (<30 mL/min) renal impairment

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Subjects with normal renal function: Subjects must be healthy with estimated creatinine clearance >80 mL/min
Subjects with renal impairment: Subjects should be in good general health commensurate with the population with chronic kidney disease

Key exclusion criteria (3 listed)

Kidney transplant patients
Subjects with any condition possibly affecting drug absorption
Subjects with malignancies with the exception of adequately treated basal cell carcinoma of the skin

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
CP-690,55010 mg (2 x 5 mg tablets), single dose	Drug	Healthy volunteers
CP-690,55010 mg (2 x 5 mg tablets), single dose	Drug	Mild renal impairment
CP-690,55010 mg (2 x 5 mg tablets), single dose	Drug	Moderate renal impairment
CP-690,55010 mg (2 x 5 mg tablets), single dose	Drug	severe renal impairment

Primary outcome

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
Time frame: 0 (Pre-dose), 0.5, 1, 1.5, 2, 4, 8, 10, 12, 16, 24, 48 hours post-dose
AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
Maximum Observed Plasma Concentration (Cmax)
Time frame: 0 (Pre-dose), 0.5, 1, 1.5, 2, 4, 8, 10, 12, 16, 24, 48 hours post-dose
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: 0 (Pre-dose), 0.5, 1, 1.5, 2, 4, 8, 10, 12, 16, 24, 48 hours post-dose
Plasma Decay Half-Life (t1/2)
Time frame: 0 (Pre-dose), 0.5, 1, 1.5, 2, 4, 8, 10, 12, 16, 24, 48 hours post-dose
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Renal Clearance (CL R)
Time frame: 0 (Pre-dose) to 12 hours post-dose, 12 to 24 hours post-dose
Renal clearance is the volume of plasma from which the drug is completely removed by the kidney in a given amount of time.

Results and safety

Results posted to the registry on 7 Jan 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
CP-690,550 (Normal Renal Function)	6	6
CP-690,550 (Mild Renal Insufficiency)	6	6
CP-690,550 (Moderate Renal Insufficiency)	6	6
CP-690,550 (Severe Renal Insufficiency)	6	6

Primary outcome: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]

Time frame: 0 (Pre-dose), 0.5, 1, 1.5, 2, 4, 8, 10, 12, 16, 24, 48 hours post-dose. Mean (Standard Deviation). Unit: nanogram*hour/milliliter (ng*hr/mL)

Measure	CP-690,550 (Normal Renal Function) n = 6	CP-690,550 (Mild Renal Insufficiency) n = 6	CP-690,550 (Moderate Renal Insufficiency) n = 6	CP-690,550 (Severe Renal Insufficiency) n = 6
Value	268 (71.5)	370 (109)	396 (154)	615 (214)

CP-690,550 (Normal Renal Function) vs CP-690,550 (Mild Renal Insufficiency): Ratio of adjusted geometric means: 137.26 (90% CI 96.77 to 194.69)
CP-690,550 (Normal Renal Function) vs CP-690,550 (Moderate Renal Insufficiency): Ratio of adjusted geometric means: 142.59 (90% CI 100.53 to 202.24)
CP-690,550 (Normal Renal Function) vs CP-690,550 (Severe Renal Insufficiency): Ratio of adjusted geometric means: 222.71 (90% CI 157.02 to 315.89)

Population analysed: Analysis set included all participants who received study medication.

Primary outcome: Maximum Observed Plasma Concentration (Cmax)

Time frame: 0 (Pre-dose), 0.5, 1, 1.5, 2, 4, 8, 10, 12, 16, 24, 48 hours post-dose. Mean (Standard Deviation). Unit: ng/mL

Measure	CP-690,550 (Normal Renal Function) n = 6	CP-690,550 (Mild Renal Insufficiency) n = 6	CP-690,550 (Moderate Renal Insufficiency) n = 6	CP-690,550 (Severe Renal Insufficiency) n = 6
Value	94.2 (25.3)	87.3 (23.2)	104 (47.5)	111 (28.6)

CP-690,550 (Normal Renal Function) vs CP-690,550 (Mild Renal Insufficiency): Ratio of adjusted geometric mean: 93.15 (90% CI 67.22 to 129.06)
CP-690,550 (Normal Renal Function) vs CP-690,550 (Moderate Renal Insufficiency): Ratio of adjusted geometric mean: 104.17 (90% CI 75.18 to 144.34)
CP-690,550 (Normal Renal Function) vs CP-690,550 (Severe Renal Insufficiency): Ratio of adjusted geometric mean: 117.65 (95% CI 84.91 to 163.02)

Population analysed: Analysis set included all participants who received study medication.

Primary outcome: Time to Reach Maximum Observed Plasma Concentration (Tmax)

Time frame: 0 (Pre-dose), 0.5, 1, 1.5, 2, 4, 8, 10, 12, 16, 24, 48 hours post-dose. Median (Full Range). Unit: hours

Measure	CP-690,550 (Normal Renal Function) n = 6	CP-690,550 (Mild Renal Insufficiency) n = 6	CP-690,550 (Moderate Renal Insufficiency) n = 6	CP-690,550 (Severe Renal Insufficiency) n = 6
Value	0.75 (0.50 to 1.50)	1.00 (0.50 to 1.50)	0.75 (0.50 to 2.00)	0.75 (0.50 to 1.50)

Population analysed: Analysis set included all participants who received study medication.

Primary outcome: Plasma Decay Half-Life (t1/2)

Time frame: 0 (Pre-dose), 0.5, 1, 1.5, 2, 4, 8, 10, 12, 16, 24, 48 hours post-dose. Mean (Standard Deviation). Unit: hours

Measure	CP-690,550 (Normal Renal Function) n = 6	CP-690,550 (Mild Renal Insufficiency) n = 6	CP-690,550 (Moderate Renal Insufficiency) n = 6	CP-690,550 (Severe Renal Insufficiency) n = 6
Value	2.37 (0.363)	2.83 (0.857)	2.88 (0.653)	3.77 (0.480)

Population analysed: Analysis set included all participants who received study medication.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CP-690,550 (Normal Renal Function)	0 of 6 (0%)	0 of 6 (0%)	Not reported
CP-690,550 (Mild Renal Insufficiency)	0 of 6 (0%)	0 of 6 (0%)	Not reported
CP-690,550 (Moderate Renal Insufficiency)	0 of 6 (0%)	3 of 6 (50%)	Not reported
CP-690,550 (Severe Renal Insufficiency)	0 of 6 (0%)	1 of 6 (16.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24030917Krishnaswami S, Chow V, Boy M, Wang C, Chan G. Pharmacokinetics of tofacitinib, a janus kinase inhibitor, in patients with impaired renal function and end-stage renal disease. J Clin Pharmacol. 2014 Jan;54(1):46-52. doi: 10.1002/jcph.178. Epub 2013 Sep 30.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Renal Impairment

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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

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CP-690,550 in people with Renal Impairment, run by Pfizer at 4 sites in United States.

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 2 inclusion and 3 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 7 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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. 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 7 Jan 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?

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] (time frame: 0 (Pre-dose), 0.5, 1, 1.5, 2, 4, 8, 10, 12, 16, 24, 48 hours post-dose). The study lists 5 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 NCT01740362, which also lists 1 linked publication.

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 7 Jan 2013.