Clofutriben in people with moderate kidney impairment
Official title: Clofutriben Pharmacokinetics in Patients With Impaired Renal Function
Run by Sparrow Pharmaceuticals · NCT07227922 · Data updated 2026-11-12
This trial will test how a single 12 mg dose of clofutriben behaves in people with moderate kidney impairment compared with matched people with normal kidney function.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 83 Years |
| Sex | All |
| Enrollment | 16 (estimated) |
| Sponsor | Sparrow Pharmaceuticals Industry-sponsored |
| Locations | 1 site (Orlando, Florida) |
| Status | Recruiting |
| Started | November 30, 2025 |
| Main results expected | April 30, 2026 |
| Study ends | July 1, 2026 |
| Registry record updated | December 23, 2025 |
| Trial ID | NCT07227922 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with stable moderate renal impairment (eGFR 30 to <60 mL/min) who can be matched by age, sex, and weight to a control with normal renal function are ideal candidates.
✕Probably not a fit
People with severe or unstable kidney disease, significant ECG or lab abnormalities, or other conditions or medications that increase safety risk are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase 1, single-center, open-label, single-dose pharmacokinetic study enrolling 16 participants: eight with stable moderate renal impairment and eight matched controls with normal renal function. After screening, participants will be confined to a clinical research unit for six days and receive a single oral 12 mg dose of clofutriben. Blood and other samples will be collected over the confinement period to characterize clofutriben pharmacokinetics, and safety and tolerability will be monitored. A safety follow-up will be conducted by telephone four weeks after dosing.
Why it matters
Potential benefit: If successful, the results could help clinicians choose safer, more appropriate dosing for patients with moderate renal impairment.
How similar studies have gone: Pharmacokinetic comparisons between renal impairment groups and normal controls are a common, established approach that often informs dosing recommendations, though each drug must be evaluated individually.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male and female participants with stable moderate renal impairment (estimated glomerular filtration rate \[eGFR\]: 30 to \<60 mL/min) and matched (by sex, age, and weight) control participants with normal renal function (eGFR: ≥90 mL/min) will be enrolled in this trial. Exclusion Criteria: * Participant whose current or recent medical conditions, medications, or procedures could increase participant's safety risk, or whom the Investigator considers not suitable for entry into the trial or the participant, or who has clinically significant abnormal 12-lead electrocardiogram (ECG)/ vital sign measurements/ laboratory test results at Screening and Check-in, will not be enrolled
Where it's running
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Orlando Clinical Research Center
Orlando, Florida, United States Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.