A Phase 1 interventional study of Prifetrastat in Renal Impairment and Healthy Adults, sponsored by Pfizer. Not yet recruiting at 3 sites in United States. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by Pfizer · Phase 1, Interventional, and Other
Among 37 studies in Renal Insufficiency by Pfizer — 2 open to participants now, 3 under way, none of them phase 3. Renal Insufficiency · Pfizer.
Among the 37 studies in Renal Insufficiency by Pfizer, this one is the 21st largest by planned enrollment of the 36 interventional ones that give a count, is one of 3 that started in 2026, is one of 23 in phase 1, and was the 37th registered.
1,409 studies on the registry are indexed under Renal Insufficiency; 143 are open to participants now.
Browse Renal Insufficiency studies →2 of the 37 studies in Renal Insufficiency by Pfizer are open now, in 1 country. Recruiting first, the newest first:
Pfizer · Sites in United States
Ages 18–80 · Healthy volunteers
By country, each count listing its studies:
Of the 90 Renal Insufficiency studies recruiting now, 47 (52%) set no upper age limit and 18 (20%) stop at 75 or younger; 8 take children under 18; 15 take healthy volunteers.
This study: 18 Years to 90 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
37 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 24 · Phase 2 1 · Phase 3 4 · Phase 4 8
First in 2002; this study’s year is marked. 3 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 24 is below the median of 40 across 1,058 interventional studies indexed under Renal Insufficiency.
Median enrollment 30 across the 36 interventional studies, 59 across the 1 observational. Of the 34 that completed or were terminated, 15 (44%) have results posted.
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Pfizer is the lead sponsor of 3,337 studies on the registry; 150 are open to participants now.
Of its 601 completed or terminated interventional studies of FDA-regulated products, 392 (65%) have results posted.
1 of the studies in Renal Insufficiency by Pfizer that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07315360PfizerA Study to Learn How the Body Processes the Study Medicine PF-07328948 in People With Reduced Kidney Function | 2027-03-13 |
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Among the 37 studies in Renal Insufficiency by Pfizer, from their registry updates:
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The primary purpose of this study is to understand how the body processes the study medicine, called prifetrastat, in people with renal impairment compared to healthy people with normal kidney function. Renal impairment means that a person has worse kidney function than normal. The study will also look at the safety and tolerability of prifetrastat in people with renal impairment compared to healthy people with normal kidney function.
This study is seeking participants who:
All participants in this study will receive a single dose of prifetrastat. The study medicine will be given by mouth at the study clinic. We will compare experiences of people with renal impairment and healthy people with normal kidney function.
Participants will take part in this study for about 2 months. During this time, they will stay at the study clinic for 8 to 16 days.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Prifetrastat administered by mouth as a single dose in participants with moderate renal impairment (eGFR = 30-59 mL/min).
Drug: Prifetrastat
Prifetrastat administered by mouth as a single dose in participants with severe renal impairment (eGFR \< 30 mL/min).
Drug: Prifetrastat
Prifetrastat administered by mouth as a single dose in participants with normal renal function (eGFR ≥ 90 mL/min).
Drug: Prifetrastat
Prifetrastat administered by mouth as a single dose.
Also known as: PF-07248144
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of Prifetrastat
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, 264, 312, and 360 hours post-dose
Maximum Observed Plasma Concentration (Cmax) of Prifetrastat
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, 264, 312, and 360 hours post-dose
Number of Treatment-Emergent Adverse Events (AE) by Severity
Time frame: From Baseline through follow-up, up to 35 days after last dose of study drug
Number of Participants With Clinically Significant Clinical Laboratories Abnormalities
Time frame: From Baseline through follow-up, up to 35 days after last dose of study drug
Number of Participants With Clinically Significant Change From Baseline in Blood Pressure or Heart Rate
Time frame: From Baseline up to Day 16
Number of Participants With Abnormalities in Physical Examination
Time frame: From Baseline up to Day 16
Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Findings
Time frame: From Baseline up to Day 16
Plan to share: 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.
Start is estimated for Nov 2026; primary completion for May 2028, 18 months later.
Of 212 industry-sponsored phase 1 interventional studies under Renal Insufficiency, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 15. This study's planned 18 months is above that.
Counting every sponsor, half of 230 studies reached it within 8 months; a quarter within 5 and three quarters within 16.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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