Renal ImpairmentPhase 1NCT03660241

A Renal Impairment Study for PF-04965842

A Phase 1 study testing PF-04965842 in people with Renal Impairment, run by Pfizer at 4 sites in 2 countries.

Completed

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

Trial summary

This study is a phase 1 non-randomized, open-label, single-dose, parallel-group study of PF 04965842 in subjects with severe renal impairment and subjects without renal impairment (Part 1) and in subjects with moderate renal impairment (Part 2). Read more about this study

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Renal Impairment
What is being tested?: PF-04965842
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 23 participants
Where: 4 sitesin 2 countries
Study dates: 5 Oct 2018to 5 Nov 2019
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

Breath alcohol test at Screening and Day -1 must be negative.
Body mass index (BMI) of ≥ 17.5 to ≤ 40.0 kg/m2; and a total body weight >50 kg (110 lb).
Additional inclusion criteria for subjects with renal impairment:
Meet the following eGFR criteria during the screening period based on the MDRD equation:
Severe renal impairment: eGFR <30 mL/min, but not requiring hemodialysis.
Moderate renal impairment (Part 2 only): eGFR ≥30 mL/min and <60 mL/min.
Any form of renal impairment except acute nephritic syndrome (subjects with history of previous nephritic syndrome but in remission can be included).
Stable concomitant drug regimen.

Who cannot join

Renal transplant recipients.
Urinary incontinence without catheterization.
Subjects with clinically significant infections within the past 3 months (for example, those requiring hospitalization, or as judged by the Investigator), evidence of any infection (including influenza) within the past 7 days prior to baseline, history of disseminated herpes simplex infection or recurrent or disseminated herpes zoster.
Subjects with a malignancy or with a history of malignancy, with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
History of or current positive results for human immunodeficiency virus, Hepatitis B, Hepatitis C.
Additional exclusion criteria for subjects with renal impairment:

Show all 9Show fewer

Subjects requiring hemodialysis and peritoneal dialysis.
Screening BP ≥ 180 mm Hg (systolic) or ≥ 110 mm Hg (diastolic).
Screening supine 12-lead ECG demonstrating QTcF >470 msec or a QRS interval >120 msec.

Trial locations and contacts

4 sites in 2 countries.

Country

City, postcode or hospital

4 sites in 2 countries

United States3 sites

University of Miami Division of Clinical Pharmacology
Miami, Florida, 33136
University of Miami, Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
Orlando Clinical Research Center
Orlando, Florida, 32809

Other trials in United States

Belgium1 site

Brussels Clinical Research Unit
Brussels, Be-bru, B-1070

Other trials in Belgium

About this study

Official title: A PHASE 1, NON-RANDOMIZED, OPEN-LABEL, SINGLE-DOSE STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF PF-04965842 IN SUBJECTS WITH RENAL IMPAIRMENT AND IN HEALTHY SUBJECTS WITH NORMAL RENAL FUNCTION

Read the detailed description

This is a Phase 1 non randomized, open label, single dose, parallel cohort, multisite study to investigate the effect of renal impairment on the pharmacokinetics, safety and tolerability of PF-04965842 after a single 200 mg oral dose. Subjects will be selected and categorized into normal renal function or renal impairment groups based on their estimated glomerular filtration rate. Part 1: A total of approximately16 subjects will be enrolled; approximately 8 subjects with severe renal impairment and approximately 8 with normal renal function. After statistical evaluation of results from Part 1, Part 2 may be conducted and approximately 8 subjects with moderate renal impairment will be enrolled. The total duration of participation from the Screening Visit to Day 4 will be a maximum of 31 days and from the Screening Visit to Follow-up Contact/Visit will be a maximum of 67 days.

Conditions: Renal Impairment
Being tested: PF-04965842
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-04965842Drug
PF 04965842 is a janus kinase (JAK) 1 inhibitor that is currently being developed for the treatment of atopic dermatitis (AD).

Study groups in NCT03660241
Study group	Role	What they receive
PF-04965842	Experimental	PF 04965842 is an oral selevtive janus kinase (JAK) 1 inhibitor Receives: Drug: PF-04965842

What is being measured

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

Maximum Observed Plasma Concentration (Cmax) for PF-04965842
Maximum observed plasma PF-04965842 concentration.
Measured: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose
Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) for PF-04965842
Area under the plasma PF-04965842 concentration-time profile from time 0 extrapolated to infinite time.
Measured: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose.
Maximum Observed Plasma Concentration (Cmax) for PF-06471658 (M1)
Maximum observed plasma concentration for active metabolite, PF-06471658 (M1).
Measured: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose.
Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) for PF-06471658 (M1)
Area under the plasma concentration-time profile from time 0 extrapolated to infinite time for active metabolite, PF-06471658 (M1).
Measured: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose.
Maximum Observed Plasma Concentration (Cmax) for PF-07055087 (M2)
Maximum observed plasma concentration for active metabolite, PF-07055087 (M2).
Measured: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose.
Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) for PF-07055087 (M2)
Area under the plasma concentration-time profile from time 0 extrapolated to infinite time for active metabolite, PF-07055087 (M2).
Measured: 0 (pre-dose), and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose.

Secondary outcomes (4)

Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Adverse events (AEs): any untoward medical occurrence in a clinical investigation subject administered a product or medical device, without regard to causality. Treatment-emergent AEs (TEAEs): AEs which occurred for the first time during the effective duration of treatment or AEs that increased in severity during treatment. Serious AEs (SAEs) were any untoward medical occurrence at any dose that resulted in death; was life-threatening; required inpatient hospitalization or caused prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduction normal life functions). AEs included SAEs and non-serious AEs. Treatment-related TEAEs were any untoward medical occurrence attributed to study treatment. Causality to study treatment was determined by the investigator.
Measured: Baseline up to Follow-Up (Day 36)
Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)
Protocol-required safety laboratory assessments included chemistry, hematology, and urinalysis (and microscopy, if needed). Each parameter was evaluated against commonly used and widely accepted criteria.
Measured: Baseline, post-dose on Day 1, Day 2 and Day 4.
Number of Participants With Clinically Significant Vital Sign Values
Vital sign data included blood pressure and pulse rate. Clinical significance was assessed by the investigator.
Measured: Day 1 (pre-dose) and Day 4
Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Values
Clinical significance of ECG data was assessed by the investigator.
Measured: Baseline, post-dose on Day 1 and on Day 4

Timeline

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

5 Oct 20185 Nov 2019

First posted6 Sep 2018
Study start5 Oct 2018
Primary completion5 Nov 2019
Study completion5 Nov 2019

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: Not applicable
Intervention model: Parallel groups
Model description: Part 1 will be conducted. The 8 subjects from the renal impaired group will be recruited before recruiting the 8 subjects without renal impairment function in Part 1. After statistical evaluation of results from Part 1, Part 2 may be conducted.
Masking: None (open label)
Enrolment: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03660241
Sponsor's protocol ID: B7451021
Other IDs: 2018-002865-20, 2018
Status last verified: Mar 2022
First submitted: 4 Sep 2018
Last updated: 22 Mar 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: 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

Wang EQ, Le V, Winton JA, Tripathy S, Raje S, Wang L, Dowty ME, Malhotra BK. Effects of Renal Impairment on the Pharmacokinetics of Abrocitinib and Its Metabolites. J Clin Pharmacol. 2022 Apr;62(4):505-519. doi: 10.1002/jcph.1980. Epub 2022 Feb 15.
PubMed 34637151

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

RecruitingPhase 2
Neurovascular Regulation During Exercise in Humans With Chronic Kidney Disease: Sympatholysis in CKD
Chronic Kidney Disease
Not yet recruiting
Combined Versus Multicomponent Training in People With Chronic Kidney Disease Stages 3a and 3b
Chronic Kidney Disease Stage 3A, Chronic Kidney Disease Stage 3B
RecruitingPhase 4
Effect of a Furosemide Stress Test-Guided Strategy on Liberation From Continuous Renal Replacement Therapy in Critically Ill Patients With Acute Kidney Injury
Acute Kidney Injury
Recruiting
Dry Weight Reduction Intervention Via Extra Ultrafiltration
Fluid Accumulation, Blood Pressure Management
Not yet recruiting
Cycling During Dialysis: A Feasibility and Safety Study
Hemodialysis, Kidney Disease, End-Stage

All Renal Impairment trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A PHASE 1, NON-RANDOMIZED, OPEN-LABEL, SINGLE-DOSE STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF PF-04965842 IN SUBJECTS WITH RENAL IMPAIRMENT AND IN HEALTHY SUBJECTS WITH NORMAL RENAL FUNCTION
ClinicalTrials.gov ID: NCT03660241
Acronym / sponsor ID: B7451021
Conditions: Renal Impairment
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 23 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 5 Oct 2018 (actual)
Primary completion: 5 Nov 2019 (actual)
Study completion: 5 Nov 2019 (actual)
First posted: 6 Sep 2018 (actual)
Results: Posted 17 Dec 2020

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

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 1
Model description: Part 1 will be conducted. The 8 subjects from the renal impaired group will be recruited before recruiting the 8 subjects without renal impairment function in Part 1. After statistical evaluation of results from Part 1, Part 2 may be conducted.

Arm	Type	Receives
PF-04965842	Experimental	Drug: PF-04965842PF 04965842 is an oral selevtive janus kinase (JAK) 1 inhibitor

Who may qualify

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

Key inclusion criteria (8 listed)

Breath alcohol test at Screening and Day -1 must be negative.
Body mass index (BMI) of ≥ 17.5 to ≤ 40.0 kg/m2; and a total body weight >50 kg (110 lb).
Meet the following eGFR criteria during the screening period based on the MDRD equation:
Any form of renal impairment except acute nephritic syndrome (subjects with history of previous nephritic syndrome but in remission can be included).
Stable concomitant drug regimen.

Key exclusion criteria (9 listed)

Renal transplant recipients.
Urinary incontinence without catheterization.
Subjects with clinically significant infections within the past 3 months (for example, those requiring hospitalization, or as judged by the Investigator), evidence of any infection (including influenza) within the past 7 days prior to baseline, history of disseminated herpes simplex infection or recurrent or disseminated herpes zoster.
Subjects with a malignancy or with a history of malignancy, with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
History of or current positive results for human immunodeficiency virus, Hepatitis B, Hepatitis C.

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-04965842PF 04965842 is a janus kinase (JAK) 1 inhibitor that is currently being developed for the treatment of atopic dermatitis (AD).	Drug	PF-04965842

Primary outcome

Maximum Observed Plasma Concentration (Cmax) for PF-04965842
Time frame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose
Maximum observed plasma PF-04965842 concentration.
Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) for PF-04965842
Time frame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose.
Area under the plasma PF-04965842 concentration-time profile from time 0 extrapolated to infinite time.
Maximum Observed Plasma Concentration (Cmax) for PF-06471658 (M1)
Time frame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose.
Maximum observed plasma concentration for active metabolite, PF-06471658 (M1).
Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) for PF-06471658 (M1)
Time frame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose.
Area under the plasma concentration-time profile from time 0 extrapolated to infinite time for active metabolite, PF-06471658 (M1).
Maximum Observed Plasma Concentration (Cmax) for PF-07055087 (M2)
Time frame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose.
Maximum observed plasma concentration for active metabolite, PF-07055087 (M2).
Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) for PF-07055087 (M2)
Time frame: 0 (pre-dose), and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose.
Area under the plasma concentration-time profile from time 0 extrapolated to infinite time for active metabolite, PF-07055087 (M2).

4 secondary outcomes

Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Baseline up to Follow-Up (Day 36)
Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)
Time frame: Baseline, post-dose on Day 1, Day 2 and Day 4.
Number of Participants With Clinically Significant Vital Sign Values
Time frame: Day 1 (pre-dose) and Day 4
Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Values
Time frame: Baseline, post-dose on Day 1 and on Day 4

Results and safety

Results posted to the registry on 17 Dec 2020, 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
Moderate Renal Impairment	7	7
Severe Renal Impairment	8	8

Primary outcome: Maximum Observed Plasma Concentration (Cmax) for PF-04965842

Time frame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: nanogram per milliliter (ng/mL)

Measure	Normal Renal Function n = 8	Moderate Renal Impairment n = 7	Severe Renal Impairment n = 8
Value	1174 (56)	1626 (31)	1164 (80)

Normal Renal Function vs Moderate Renal Impairment: Ratio of adjusted geometric means: 138.49 (90% CI 93.74 to 204.61), ANOVA
Normal Renal Function vs Severe Renal Impairment: Ratio of adjusted geometric means: 99.11 (90% CI 57.30 to 171.43), ANOVA

Population analysed: The analysis population refers to all participants dosed who had at least 1 of the PK parameters of primary interest.

Primary outcome: Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) for PF-04965842

Time frame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose.. Geometric mean (Geometric Coefficient of Variation). Unit: nanogram*hour per milliliter (ng*hr/mL)

Measure	Normal Renal Function n = 8	Moderate Renal Impairment n = 7	Severe Renal Impairment n = 7
Value	4827 (65)	8828 (37)	5855 (73)

Normal Renal Function vs Moderate Renal Impairment: Ratio of adjusted geometric means: 182.91 (90% CI 117.09 to 285.71), ANOVA
Normal Renal Function vs Severe Renal Impairment: Ratio of adjusted geometric means: 121.32 (90% CI 68.32 to 215.41), ANOVA

Population analysed: The analysis population refers to all participants dosed who had at least 1 of the PK parameters of primary interest.

Primary outcome: Maximum Observed Plasma Concentration (Cmax) for PF-06471658 (M1)

Time frame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose.. Geometric mean (Geometric Coefficient of Variation). Unit: nanogram per milliliter (ng/mL)

Measure	Normal Renal Function n = 8	Moderate Renal Impairment n = 7	Severe Renal Impairment n = 8
Value	193.7 (54)	192.8 (65)	325.0 (81)

Normal Renal Function vs Moderate Renal Impairment: Ratio of adjusted geometric means: 99.51 (90% CI 59.80 to 165.57), ANOVA
Normal Renal Function vs Severe Renal Impairment: Ratio of adjusted geometric means: 167.79 (90% CI 97.20 to 289.64), ANOVA

Population analysed: The analysis population refers to all participants dosed who had at least 1 of the PK parameters of primary interest.

Primary outcome: Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) for PF-06471658 (M1)

Time frame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose.. Geometric mean (Geometric Coefficient of Variation). Unit: nanogram*hour/milliliter (ng*hr/mL)

Measure	Normal Renal Function n = 8	Moderate Renal Impairment n = 7	Severe Renal Impairment n = 8
Value	872.6 (44)	1346 (43)	2505 (45)

Normal Renal Function vs Moderate Renal Impairment: Ratio of adjusted geometric means: 154.22 (90% CI 105.11 to 226.26), ANOVA
Normal Renal Function vs Severe Renal Impairment: Ratio of adjusted geometric means: 287.06 (90% CI 196.72 to 418.89), ANOVA

Population analysed: The analysis population refers to all participants dosed who had at least 1 of the PK parameters of primary interest.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline up to Follow-Up (Day 36). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Normal Renal Function	0 of 8 (0%)	1 of 8 (12.5%)	0 of 8
Moderate Renal Impairment	0 of 7 (0%)	1 of 7 (14.3%)	0 of 7
Severe Renal Impairment	0 of 8 (0%)	0 of 8 (0%)	0 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34637151Wang EQ, Le V, Winton JA, Tripathy S, Raje S, Wang L, Dowty ME, Malhotra BK. Effects of Renal Impairment on the Pharmacokinetics of Abrocitinib and Its Metabolites. J Clin Pharmacol. 2022 Apr;62(4):505-519. doi: 10.1002/jcph.1980. Epub 2022 Feb 15.
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.

Related trials for Renal Impairment

RecruitingPhase 2
Neurovascular Regulation During Exercise in Humans With Chronic Kidney Disease: Sympatholysis in CKD
Chronic Kidney Disease
Not yet recruiting
Combined Versus Multicomponent Training in People With Chronic Kidney Disease Stages 3a and 3b
Chronic Kidney Disease Stage 3A, Chronic Kidney Disease Stage 3B
RecruitingPhase 4
Effect of a Furosemide Stress Test-Guided Strategy on Liberation From Continuous Renal Replacement Therapy in Critically Ill Patients With Acute Kidney Injury
Acute Kidney Injury
Recruiting
Dry Weight Reduction Intervention Via Extra Ultrafiltration
Fluid Accumulation, Blood Pressure Management
Not yet recruiting
Cycling During Dialysis: A Feasibility and Safety Study
Hemodialysis, Kidney Disease, End-Stage

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 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PF-04965842 in people with Renal Impairment, run by Pfizer at 4 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 8 inclusion and 9 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 22 Mar 2022. 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, Belgium. 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 17 Dec 2020). 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?

Maximum Observed Plasma Concentration (Cmax) for PF-04965842 (time frame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose). The study lists 6 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 NCT03660241, 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 22 Mar 2022.