Status:
WITHDRAWN
A Study to Learn How the Study Treatment BAY2395840 Moves Into, Through and Out of the Body, How Safe it is, and How it Affects the Body in Participants With Moderate Reduced Kidney Function and in Healthy Male and Female Participants With Normal Kidney Function
Lead Sponsor:
Bayer
Conditions:
Diabetic Neuropathic Pain
Renal Impairment
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Researchers are looking for a better way to treat people who have inflammatory conditions. Inflammatory conditions may result from an increased activation of the body's natural defenses (the immune s...
Eligibility Criteria
Inclusion
- Participants must be 18 years of age or older, at the time of signing the informed consent.
- Participants who are - apart from renal function - overtly healthy for their age as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
- Participants with moderate renal impairment with an eGFR of 30 to 59 mL/min/1.73 m\^2 (inclusive) according to the Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI)
- Normal renal function, as assessed by estimated glomerular filtration rate (eGFR) based on serum creatinine at screening according to the modified Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI) formula: eGFR ≥90 mL/min/1.73 m\^2. For participants with an age of 65 years and older, an eGFR of ≥ 60 mL/min/1.73 m\^2 is acceptable.
- Body mass index (BMI) within the range 18 - 32 kg/m\^2 (inclusive).
- Male and female participants had to use safe contraception, as defined by guidelines for contraception in clinical studies.
- Capable of giving signed informed consent.
Exclusion
- Medical disorder, condition or history of such that would impair the participant's ability to take part in or complete this study.
- Acute renal failure or acute nephritis within the past 2 years.
- Existing chronic diseases requiring medication (applicable only for Group 2 and Group 3 for those younger than 65 years).
Key Trial Info
Start Date :
May 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 12 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05406219
Start Date
May 15 2023
End Date
October 12 2023
Last Update
April 19 2023
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