Can a damaged kidney change how antibiotics work?
NCT ID NCT07758608
First seen Aug 11, 2026 · Last updated Aug 25, 2026 · Updated 3 times
Summary
This trial is investigating how different levels of kidney function affect the way the body processes a single dose of the antibiotic afabicin. About 60 adults with varying degrees of kidney impairment, from mild to severe, will receive either an oral tablet or an intravenous infusion of the drug. Researchers will measure drug levels in the blood over time to see if kidney function alters how the drug is absorbed and cleared. The goal is to understand whether dose adjustments are needed for people with kidney problems.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- afabicin (oral or intravenous)
- What this could lead to
- If successful, this could help determine the right afabicin dose for people with kidney problems, making the antibiotic safer and more effective for them.
- What could go wrong
- This is an early-stage trial with a single dose, so results may not reflect real-world use. Kidney impairment may alter drug levels in unexpected ways, and the study is not designed to test how well the drug works.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Signed and dated written informed consent obtained before undertaking any trial-specific procedures. 2. Body Mass Index (BMI): 18.5 to 35.0 kilograms per square meter (kg/m\^2), inclusive, at screening. 3. Nonsmoker (confirmed by urine cotinine \<500 nanograms per milliliter (ng/mL)) and have not used nicotine or nicotine containing products for the last month before screening. 4. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other trial procedures. 5. Stable renal function. Renal function must be considered stable by the Investigator. The screening eGFR, calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) 2021 formula and adjusted for body surface area (multiplied by individual BSA/1.73 m\^2), will be used for group allocation: 1. For participants with normal renal function: eGFR ≥90 mL/min 2. For participants with mild renal impairment: eGFR ≥60 to \<90 mL/min 3. For participants with moderate renal impairment: eGFR ≥30 to \<60 mL/min 4. For participants with severe renal impairment and kidney failure not receiving dialysis: eGFR \<30 mL/min 6. Confirmation of renal function prior to dosing. Renal function stability must be confirmed on Day -1. The eGFR determined on Day -1, obtained at least 3 days apart from screening, must not deviate by more than 25 percent (%) from the eGFR value obtained at screening. Exclusion Criteria: 1. Any clinically significant symptoms of an infectious illness (bacterial, viral or parasitic) within 2 weeks prior to first dosing or a history of recurrent infections (≥3 infections requiring medical intervention in the 6 months prior to ICF signature). 2. History of chronic drug or alcohol abuse in the last 4 years. 3. A positive result in the alcohol and/or urine drug abuse evaluations at screening or admission on Day -1, unless the result is attributable to a prescribed medication used to treat comorbidities associated with chronic kidney disease or another stable condition. 4. History of investigational medication use within 3 months or 5 half-lives of the drug (whichever is longer) prior to administration the trial drug. 5. Blood loss or donation of blood over 500 milliliter (mL) within 3 months prior to screening. 6. Uncontrolled hypertension, defined as systolic blood pressure greater than (\>)160 millimeters of mercury (mm Hg) or diastolic blood pressure \>100 mm Hg on average of 3 measurements at screening. Screening measurements should be conducted with participants on baseline anti-hypertensive regimen. 7. History and/or presence of any clinically significant disease or disorder, such as cardiovascular, pulmonary, renal (for participants with normal renal function), hepatic, neurological, gastrointestinal, endocrine, psychiatric or mental disease or disorder, or mental or legal incapacitation, which, in the opinion of the Investigator, may either put the participant at risk due to participation in the trial, influence the results of the trial, or influence the participant's ability to participate in the trial. 8. History of uric acid stone disease in the last 5 years. 9. History of chronic pancreatitis or idiopathic acute pancreatitis. 10. Participants with renal transplant or renal carcinoma (participants with a history of renal carcinoma could be included if cancer free for \>10 years). 11. A potassium concentration \>6.1 millimoles per liter (mmol/L) at screening or Day -1. 12. Plasma albumin \<3.0 grams per deciliter (g/dL) and/or proteinuria \>3.5 grams per day (g/day) at screening. 13. A history of nephrotic syndrome. Note: Other protocol-specified inclusion/exclusion criteria may apply.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Charite Research Organisation
Berlin, 10117, Germany
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Other studies related to the condition(s) this trial covers.
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