Kidney health may change how drug works in body
NCT ID NCT06589713
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looked at how different levels of kidney function affect the way the drug enpatoran moves through the body. 34 adults with normal or impaired kidney function received a single dose of enpatoran. Researchers measured drug levels in the blood and monitored for side effects to understand if kidney problems change how the drug is processed.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- enpatoran
- What this could lead to
- If successful, this study could help doctors determine the right dose of enpatoran for people with kidney problems, making the drug safer and more effective.
- What could go wrong
- This is an early-phase study with only 34 participants, focused on drug levels and safety, not on treating a disease. Results may not apply to all patients or lead to a treatment.
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
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
34 people
The number who actually took part.
- Started
-
Sep 2024
- Finished
-
Apr 2026
- Lead sponsor
-
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
-
18 to 80 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: For Control Group 1 (Normal Renal Function): * Medical history and physical examination without any ongoing clinically relevant findings as judged by the Investigator * No clinically relevant findings (only minor deviations) in biochemistry, hematology, coagulation, and urinalysis examinations for the age of the participant, as judged by the Investigator; absolute lymphocyte count and absolute neutrophil count must be within normal limits For Group 2 (Impaired Renal Function): * Medical history and physical examination without any ongoing clinically relevant findings except for the underlying disease leading to renal impairment and consequence diseases thereof * Chronic kidney disease * For participants under medication, stable medication for at least 1 month * Other protocol defined inclusion criteria could apply Exclusion Criteria: * History or presence of respiratory, gastrointestinal (including bariatric or other gastric surgeries, or other conditions that may affect drug absorption), hepatic (including hepatorenal syndrome), hematological, lymphatic, cardiovascular (such as ventricular dysfunction and congestive heart failure, cardiac arrythmia), psychiatric, neurological, genitourinary, immunological, dermatological, connective tissue diseases, or disorders that may affect the safety of the participant. * History of drug hypersensitivity, ascertained or presumptive allergy/hypersensitivity to the active drug substance and/or formulation ingredients; history of serious allergic reactions leading to hospitalization or any other hypersensitivity reaction in general, which may affect the safety of the participant and/or outcome of the study per the Investigator's discretion * History or presence of epilepsy, neurological disorders with seizure propensity or undiagnosed loss of consciousness, severe head trauma within 6 months or severe depression within 12 months prior to Screening), or neuropsychiatric conditions * History of serotonin syndrome * Prior history of cholecystectomy or splenectomy, and any clinically relevant surgery within 6 months prior to Screening, which might interfere with the objectives of the study or the study procedures * Other protocol defined exclusion criteria could 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.
Contacts and locations
Locations
-
CRS Clinical Research Services Kiel GmbH
Kiel, Schleswig-Holstein, 24105, Germany
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