Maintenance dialysis
Conditions
Interventions
Patients with chronic renal failure with a history of haemodialysis or peritoneal dialysis for three months or longer:Finerenone 10mg, taken orally once daily for seven consecutive days.
Patients with type 2 diabetic nephropathy:Finerenone 10mg, taken orally once daily for seven consecutive days.
Sponsors
Shanghai Changhai Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18–80 years, no gender restrictions; 2. Body Mass Index (BMI) 18–34 kg/m²; 3. Study group: patients with a confirmed diagnosis of chronic renal failure undergoing hemodialysis or peritoneal dialysis for >=3 months; Control group: Patients with a confirmed diagnosis of diabetic nephropathy, with an estimated glomerular filtration rate (eGFR) >=30 ml/min/1.73 m² and <60 ml/min/1.73 m². Matching criteria: age (difference <=5 years), gender (same), weight (BMI difference <=1); 4. Signing of informed consent.
Exclusion criteria
Exclusion criteria: 1. Individuals with a history of allergic reactions to or intolerance of finerenone; 2. Those currently taking finerenone; 3. Regular or current use of CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, ritonavir, nelfinavir, cobicistat, clarithromycin, telithromycin, nefazodone, etc.) or CYP3A4 inducers (e.g., carbamazepine, phenytoin, phenobarbital, St. John's Wort, efavirenz, etc.), other mineralocorticoid receptor antagonists (MRAs) (e.g., eplerenone, esaretide, spironolactone, canrenone), potassium-sparing diuretics (e.g., amiloride, amiloride hydrochloride), potassium supplements, trimethoprim/sulfamethoxazole; 4. Patients with Addison's disease; 5. Fasting serum potassium > 5.5 mmol/l; 6. Pregnant or lactating women; 7. Participants who have participated in a clinical trial within the past 3 months or are currently enrolled in a clinical trial; 8. Participants with acute infections, heart failure, moderate to severe hepatic impairment, or other acute, critical, or malignant conditions involving severe cardiovascular, pulmonary, hepatic, or neurological diseases; 9. Participants deemed unsuitable for this trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma finerenone and metabolite peak concentration (Cmax), area under the concentration-time curve (AUC), time to reach Cmax (Tmax), half-life (T1/2), accumulation index (AI%), steady-state plasma concentration;Area under the concentration-time curve (AUC) of plasma finerenone and metabolite ;Time to reach Cmax (Tmax) of plasma finerenone and metabolite;Half-life (T1/2) of plasma finerenone and metabolite;Accumulation index (AI%) of plasma finerenone and metabolite;Steady-state plasma concentration of plasma finerenone and metabolite;Hemodialysis clearance (CLHD);Peritoneal dialysis clearance (CLPD); | — |
Secondary
| Measure | Time frame |
|---|---|
| Dialysis clearance (Rd); | — |
Countries
China
Contacts
Public ContactZhiyong Guo
Shanghai Changhai Hospital
Outcome results
None listed