Renal InsufficiencyPhase 1NCT01791855

PF-04634817 Renal Impairment Study

A Phase 1 study testing PF-04634817 in people with Renal Insufficiency, run by Pfizer at 2 sites in United States.

Completed

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

Trial summary

Patients with renal impairment are the target population for PF-04634817. The clearance mechanism of this drug means that exposure may be increased in subjects with renal impairment. This study will investigate the effect of the drug in subjects with varying degrees of renal impairment. Read more about this study

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Renal Insufficiency
What is being tested?: PF-04634817
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 2 sitesUnited States
Study dates: 10 May 2013to 3 Sep 2013
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 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Male or female (non child bearing potential aged 18-75 years
Documented renal impairment (mild, moderate or severe using Cockcroft-Gault equation) or matched healthy volunteers (age, weight and gender)

Who cannot join

Subjects with acute renal failure
Subjects receiving, or likely to receive, CYP450 3A4 inhibitors
Abnormal ECG at screening

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Avail Clinical Research, LLC
DeLand, Florida, 32720
Unversity of Miami
Miami, Florida, 33136

Other trials in United States

About this study

Official title: A PHASE 1, SINGLE DOSE, OPEN-LABEL STUDY TO EVALUATE THE EFFECT OF RENAL IMPAIRMENT ON THE PHARMACOKINETICS OF PF-04634817

Conditions: Renal Insufficiency
Being tested: PF-04634817
Keywords: Subjects with Renal Impairment, healthy
Medical subject headings: Renal Insufficiency

What participants receive

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

PF-04634817Drug
Single 50 mg dose administered to subjects with normal renal function (creatinine clearance greater than or equal to 90 ml/min)
PF-04634817Drug
Single 50 mg dose administered to subjects with mild renal impairment (creatinine clearance 60-89 ml/min)
PF-04634817Drug
Single 50 mg dose administered to subjects with moderate renal impairment (creatinine clearance 30-59 ml/min)
PF-04634817Drug
Single 50 mg dose administered to subjects with severe renal impairment (creatinine clearance 15-29 ml/min)

Study groups in NCT01791855
Study group	Role	What they receive
Healthy Volunteers	Experimental	Not described Receives: Drug: PF-04634817
Mild Renal Impairment	Experimental	Not described Receives: Drug: PF-04634817
Moderate renal impairment	Experimental	Not described Receives: Drug: PF-04634817
Severe renal impairment	Experimental	Not described Receives: Drug: PF-04634817

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 48 Hours[AUC (0 - 48)]
AUC (0 - 48)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to 48hours.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 32, 40, 48, 56, 64, 72, 84, 96, 108, 120, 132, 144, 156, 216, 312 hours post dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 32, 40, 48, 56, 64, 72, 84, 96, 108, 120, 132, 144, 156, 216, 312 hours post dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - Inf)]
AUC (0 - inf)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 32, 40, 48, 56, 64, 72, 84, 96, 108, 120, 132, 144, 156, 216, 312 hours post dose
Apparent Oral Clearance (CL/F)
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 32, 40, 48, 56, 64, 72, 84, 96, 108, 120, 132, 144, 156, 216, 312 hours post dose
Maximum Observed Plasma Concentration (Cmax)
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 32, 40, 48, 56, 64, 72, 84, 96, 108, 120, 132, 144, 156, 216, 312 hours post dose
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 32, 40, 48, 56, 64, 72, 84, 96, 108, 120, 132, 144, 156, 216, 312 hours post dose
Apparent Volume of Distribution (Vz/F)
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 32, 40, 48, 56, 64, 72, 84, 96, 108, 120, 132, 144, 156, 216, 312 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: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 32, 40, 48, 56, 64, 72, 84, 96, 108, 120, 132, 144, 156, 216, 312 hours post dose

Secondary outcomes (3)

Amount of Unchanged Drug Excreted in Urine Over 48 Hours (Ae48)
Amount of unchanged drug excreted in urine over 48 hours (Ae48) = urine concentration x volume of urine.
Measured: 0-24, 24-48 hours post dose
Percentage of the Dose Excreted Unchanged in the Urine Over 48 Hours (Ae48%)
Percentage (%) of drug excreted unchanged in urine over 48 hours (Ae48%) = Ae48/(dose x 100).
Measured: 0-24, 24-48 post dose
Renal Clearance Over a 48-hour Interval(CLr48)
Renal clearance over a 48-hour interval (CLr48) = Ae48/AUC48.
Measured: 0-24, 24-48 hours post dose

Timeline

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

10 May 20133 Sep 2013

First posted15 Feb 2013 (estimated)
Study start10 May 2013
Primary completion3 Sep 2013
Study completion3 Sep 2013

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 InsufficiencyStudies 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: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01791855
Sponsor's protocol ID: B1261008
Other IDs: 2013-000360-29
Status last verified: Aug 2023
First submitted: 12 Feb 2013
Last updated: 1 Mar 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Publications

Tesch GH, Pullen N, Jesson MI, Schlerman FJ, Nikolic-Paterson DJ. Combined inhibition of CCR2 and ACE provides added protection against progression of diabetic nephropathy in Nos3-deficient mice. Am J Physiol Renal Physiol. 2019 Dec 1;317(6):F1439-F1449. doi: 10.1152/ajprenal.00340.2019. Epub 2019 Sep 30.
PubMed 31566438

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 Insufficiency trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A PHASE 1, SINGLE DOSE, OPEN-LABEL STUDY TO EVALUATE THE EFFECT OF RENAL IMPAIRMENT ON THE PHARMACOKINETICS OF PF-04634817
ClinicalTrials.gov ID: NCT01791855
Acronym / sponsor ID: B1261008
Conditions: Renal Insufficiency
Keywords: Subjects with Renal Impairment, healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 10 May 2013 (actual)
Primary completion: 3 Sep 2013 (actual)
Study completion: 3 Sep 2013 (actual)
First posted: 15 Feb 2013 (estimated)
Results: Posted 1 Mar 2024

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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Healthy Volunteers	Experimental	Drug: PF-04634817
Mild Renal Impairment	Experimental	Drug: PF-04634817
Moderate renal impairment	Experimental	Drug: PF-04634817
Severe renal impairment	Experimental	Drug: PF-04634817

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Male or female (non child bearing potential aged 18-75 years
Documented renal impairment (mild, moderate or severe using Cockcroft-Gault equation) or matched healthy volunteers (age, weight and gender)

Key exclusion criteria (3 listed)

Subjects with acute renal failure
Subjects receiving, or likely to receive, CYP450 3A4 inhibitors
Abnormal ECG at screening

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
PF-04634817Single 50 mg dose administered to subjects with normal renal function (creatinine clearance greater than or equal to 90 ml/min)	Drug	Healthy Volunteers
PF-04634817Single 50 mg dose administered to subjects with mild renal impairment (creatinine clearance 60-89 ml/min)	Drug	Mild Renal Impairment
PF-04634817Single 50 mg dose administered to subjects with moderate renal impairment (creatinine clearance 30-59 ml/min)	Drug	Moderate renal impairment
PF-04634817Single 50 mg dose administered to subjects with severe renal impairment (creatinine clearance 15-29 ml/min)	Drug	Severe renal impairment

Primary outcome

Area Under the Curve From Time Zero to 48 Hours[AUC (0 - 48)]
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 32, 40, 48, 56, 64, 72, 84, 96, 108, 120, 132, 144, 156, 216, 312 hours post dose
AUC (0 - 48)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to 48hours.
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 32, 40, 48, 56, 64, 72, 84, 96, 108, 120, 132, 144, 156, 216, 312 hours post dose
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - Inf)]
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 32, 40, 48, 56, 64, 72, 84, 96, 108, 120, 132, 144, 156, 216, 312 hours post dose
AUC (0 - inf)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time.
Apparent Oral Clearance (CL/F)
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 32, 40, 48, 56, 64, 72, 84, 96, 108, 120, 132, 144, 156, 216, 312 hours post dose
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Maximum Observed Plasma Concentration (Cmax)
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 32, 40, 48, 56, 64, 72, 84, 96, 108, 120, 132, 144, 156, 216, 312 hours post dose
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 32, 40, 48, 56, 64, 72, 84, 96, 108, 120, 132, 144, 156, 216, 312 hours post dose
Apparent Volume of Distribution (Vz/F)
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 32, 40, 48, 56, 64, 72, 84, 96, 108, 120, 132, 144, 156, 216, 312 hours post dose
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
Plasma Decay Half-Life (t1/2)
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 32, 40, 48, 56, 64, 72, 84, 96, 108, 120, 132, 144, 156, 216, 312 hours post dose
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

3 secondary outcomes

Amount of Unchanged Drug Excreted in Urine Over 48 Hours (Ae48)
Time frame: 0-24, 24-48 hours post dose
Percentage of the Dose Excreted Unchanged in the Urine Over 48 Hours (Ae48%)
Time frame: 0-24, 24-48 post dose
Renal Clearance Over a 48-hour Interval(CLr48)
Time frame: 0-24, 24-48 hours post dose

Results and safety

Results posted to the registry on 1 Mar 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Normal Renal Function	8	8
Mild Renal Impairment	9	8
Moderate Renal Impairment	8	8
Severe Renal Impairment	7	6

Primary outcome: Area Under the Curve From Time Zero to 48 Hours[AUC (0 - 48)]

Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 32, 40, 48, 56, 64, 72, 84, 96, 108, 120, 132, 144, 156, 216, 312 hours post dose. Geometric mean (Geometric Coefficient of Variation). Unit: Nanogram*hour/milliliter (ng*h/mL)

Measure	Normal Renal Function n = 8	Mild Renal Impairment n = 8	Moderate Renal Impairment n = 8	Severe Renal Impairment n = 7
Value	1294 (27)	1399 (42)	2024 (35)	2860 (34)

Population analysed: The pharmacokinetics (PK) parameter analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest.

Primary outcome: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

Measure	Normal Renal Function n = 8	Mild Renal Impairment n = 8	Moderate Renal Impairment n = 8	Severe Renal Impairment n = 7
Value	1467 (29)	1575 (44)	2610 (42)	3845 (37)

Population analysed: The PK parameter analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest.

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

Measure	Normal Renal Function n = 8	Mild Renal Impairment n = 8	Moderate Renal Impairment n = 7	Severe Renal Impairment n = 7
Value	1473 (29)	1584 (44)	2611 (45)	3877 (37)

Population analysed: The PK parameter analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest. N = number of participants with reportable AUC(0-inf) values.

Primary outcome: Apparent Oral Clearance (CL/F)

Measure	Normal Renal Function n = 8	Mild Renal Impairment n = 8	Moderate Renal Impairment n = 7	Severe Renal Impairment n = 7
Value	565.8 (29)	526.8 (44)	319.2 (45)	215.2 (37)

Population analysed: The PK parameter analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest. N = the number of participants with reportable CL/F values.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Normal Renal Function	0 of 8 (0%)	0 of 8 (0%)	Not reported
Mild Renal Impairment	0 of 8 (0%)	0 of 8 (0%)	Not reported
Moderate Renal Impairment	0 of 8 (0%)	0 of 8 (0%)	Not reported
Severe Renal Impairment	1 of 7 (14.3%)	3 of 7 (42.9%)	Not reported

Limitations and caveats (from the sponsor): Designation of primary and secondary endpoints was based on the discretion of the study team, as the endpoints were not characterized clearly in the study protocol.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31566438Tesch GH, Pullen N, Jesson MI, Schlerman FJ, Nikolic-Paterson DJ. Combined inhibition of CCR2 and ACE provides added protection against progression of diabetic nephropathy in Nos3-deficient mice. Am J Physiol Renal Physiol. 2019 Dec 1;317(6):F1439-F1449. doi: 10.1152/ajprenal.00340.2019. Epub 2019 Sep 30.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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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

2 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 PF-04634817 in people with Renal Insufficiency, run by Pfizer at 2 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 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 1 Mar 2024). 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 48 Hours[AUC (0 - 48)] (time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 32, 40, 48, 56, 64, 72, 84, 96, 108, 120, 132, 144, 156, 216, 312 hours post dose). The study lists 8 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 NCT01791855, 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 1 Mar 2024.