Clareo Health | Study to Learn More About the Effect of a New Drug Called BAY2327949 on the Blood Flow Through Kidneys in Adult Participants With Moderate Chronic Kidney Disease
Study to Learn More About the Effect of a New Drug Called BAY2327949 on the Blood Flow Through Kidneys in Adult Participants With Moderate Chronic Kidney Disease
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bayer
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Participant must be 18 to 75 years of age inclusive, at the time of signing the informed consent
Clinical diagnosis of CKD for at least 6 months, with eGFR ≥30 mL/min/1.73 m2 but \<60 mL/min/1.73 m2 (eGFR will be estimated at study site from serum creatinine using the Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] formula)
Copeptin level of ≥10 pmol/L at the screening visit
Men or confirmed postmenopausal women (documented by medical report verification and defined as exhibiting spontaneous amenorrhea for at least 12 months before screening or as exhibiting spontaneous amenorrhea for 6 months before screening with documented serum follicle-stimulating hormone \[FSH\] levels \>40 mIU/mL) or women without childbearing potential based on surgical treatment 6 weeks before screening such as bilateral tubal ligation, bilateral oophorectomy or hysterectomy (documented by medical report verification).
Sexually active men, who have not been surgically sterilized, must agree to use 2 reliable and acceptable methods of contraception simultaneously (whereby one method has to be applied in the man and one method in the female partner), and not to act as sperm donor. This applies for the time period between signing of the informed consent form (ICF) and 12 weeks after the last administration of study drug.
Acceptable methods of contraception include, but are not limited to, (i) condoms (male or female) with or without a spermicidal agent; (ii) diaphragm or cervical cap with spermicide; (iii) intra-uterine device; (iv) hormone-based contraception.
Participants must be able to meet the requirements of the MRI scan (e.g. physically able to fit into the scanner)
If patient is taking loop diuretics, must be able to discontinue loop diuretics in the morning of Visit 2 and Visit 3.
You may not be if
Known acute kidney diseases (incl. kidney stones) or renal conditions that in the opinion of the investigator are expected to significantly change in intensity over the study period
Clinical diagnoses of heart failure and persistent symptoms (New York Heart Association class III - IV)
Stroke, transient ischemic cerebral attack, acute coronary syndrome, hospitalization for worsening heart failure or unplanned/emergency hospitalization in the last 3 months prior to randomization
Renal allograft in place
Hepatic insufficiency classified as Child-Pugh B or C, or active hepatitis B or C at Visit 1.
Active malignancy aside from treated squamous cell or basal cell carcinoma of the skin
Dialysis for acute renal failure within the previous 6 months prior to randomization
Indication for immunosuppressants, receiving cytotoxic therapy, immunosuppressive therapy, or other immunotherapy within 6 months prior to randomization
Participant is taking concomitant medication that is:
\- A moderate or strong inhibitor of cytochrome P450 (CYP)3A
\- A moderate or strong inducer of CYP3A
\- A moderate or strong inhibitor of P-glycoprotein transport
Any medication, surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of the study intervention
Previous (i.e. within 3 months prior to randomization) or concomitant participation in another clinical study with the study intervention
Body mass index (BMI) \>35 kg/m²
Body weight exceeding 120 kg
Glycosylated hemoglobin (HbA1c) \>11% at Visit 1
History or suggestive of alcohol or substance abuse
Planned change in dose or schedule of concomitant medication within 4 weeks prior to Visit 1, or planned change during the time course of this study
Criteria which in the opinion of the investigator preclude participation for scientific reasons, for reasons of compliance, or for reasons of the participant's safety
Any other conditions which, in the opinion of the investigator or sponsor, would make the participant unsuitable for inclusion or could interfere with the participant's participation in or completion of the study
Close affiliation of the participant with the investigational site, e.g. a close relative of the investigator, dependent person (e.g. employee or student of the investigational site)
Participant is in custody by order of an authority or court of law
