Clofutriben in people with moderate kidney impairment
Clofutriben Pharmacokinetics in Patients With Impaired Renal Function
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 |
| Enrollment | 16 (estimated) |
| Ages | 18 Years to 83 Years |
| Sex | All |
| Sponsor | Sparrow Pharmaceuticals Industry-sponsored |
| Locations | 1 site (Orlando, Florida) |
| Trial ID | NCT07227922 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Orlando, Florida
- Orlando Clinical Research Center — Orlando, Florida, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.