Phase
Condition
Renal Failure
Kidney Failure (Pediatric)
Nephropathy
Treatment
Enpatoran
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
For Control Group 1 (Normal Renal Function):
Medical history and physical examination without any ongoing clinically relevantfindings 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 judgedby the Investigator; absolute lymphocyte count and absolute neutrophil count must bewithin normal limits
For Group 2 (Impaired Renal Function):
Medical history and physical examination without any ongoing clinically relevantfindings except for the underlying disease leading to renal impairment andconsequence diseases thereof
Chronic kidney disease
For participants under medication, stable medication for at least 1 month
Other protocol defined inclusion criteria could apply
Exclusion
Exclusion Criteria:
History or presence of respiratory, gastrointestinal (including bariatric or othergastric surgeries, or other conditions that may affect drug absorption), hepatic (including hepatorenal syndrome), hematological, lymphatic, cardiovascular (such asventricular dysfunction and congestive heart failure, cardiac arrythmia),psychiatric, neurological, genitourinary, immunological, dermatological, connectivetissue diseases, or disorders that may affect the safety of the participant.
History of drug hypersensitivity, ascertained or presumptiveallergy/hypersensitivity to the active drug substance and/or formulationingredients; history of serious allergic reactions leading to hospitalization or anyother hypersensitivity reaction in general, which may affect the safety of theparticipant and/or outcome of the study per the Investigator's discretion
History or presence of epilepsy, neurological disorders with seizure propensity orundiagnosed loss of consciousness, severe head trauma within 6 months or severedepression within 12 months prior to Screening), or neuropsychiatric conditions
History of serotonin syndrome
Prior history of cholecystectomy or splenectomy, and any clinically relevant surgerywithin 6 months prior to Screening, which might interfere with the objectives of thestudy or the study procedures
Other protocol defined exclusion criteria could apply
Study Design
Connect with a study center
CRS Clinical Research Services Kiel GmbH
Kiel, Schleswig-Holstein 24105
GermanyActive - Recruiting
Please Contact the Communication Center
Darmstadt, 64293
GermanySite Not Available
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