Peritoneal dialysis
Conditions
Interventions
Non-PD group-10mg(Part 1):finerenone 10mg
Non-PD group-20mg(Part 1):finerenone 20mg
PD group-10mg(Part 1):finerenone 10mg
PD group-20mg(Part 1):finerenone 20mg
Treatment group(Part 2):finerenone
Control group(Part 2):placebo
Sponsors
Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Part 1 (1) Signing a written informed consent form prior to any specific research procedure; (2) Non-peritoneal dialysis group: Patients with type 2 diabetes (T2D) and an estimated glomerular filtration rate (eGFR) (CKD-EPI) >= 60 ml/min/1.73 m², or peritoneal dialysis group: Patients with T2D who have been receiving CAPD or CCPD for at least 3 months. (3) Male or female participants aged 18 to 80 years (reproductive-age females may only be included in the study if they test negative for pregnancy at the screening visit and agree to use appropriate contraceptive measures). (4) Serum potassium =3 months, with adequate dialysis (Kt/V >=1.7 in the past 3 months). (4) Left ventricular ejection fraction (LVEF) >=40%, accompanied by clinical symptoms of heart failure, and meeting at least one of the following criteria: BNP >300 pg/ml or NT-proBNP >8000 pg/ml; left ventricular hypertrophy within the past 12 months (LVMI >110 g/m² in male patients or >90 g/m² in female patients); Hospitalization for heart failure within the past 12 months prior to enrollment; (5) Heart failure treatment regimen (including renin-angiotensin-aldosterone system inhibitors, beta-blockers, etc.) should be used consistently for at least 4 weeks. (6) Serum potassium < 4.6 mmol/L, and no potassium-lowering drugs are used (potassium-lowering drugs refer to potassium-binding resins and sodium zirconium silicate, etc., and do not include diuretics). (7) Clinically stable volume status (BCM-OH <=2L); (8) Able to understand and follow instructions related to research;
Exclusion criteria
Exclusion criteria: Part 1 (1) Known bilateral clinically significant renal artery stenosis (arterial diameter reduction > 75%); (2) HbA1c > 12%; (3) Severe gastrointestinal diseases that may affect drug absorption; (4) Severe anemia (hemoglobin 5.5 mmol/L) within the past four weeks or prior treatment with potassium-lowering therapy. (10) Cannot discontinue any of the following medications at least 4 weeks prior to screening visits: eplerenone, spironolactone, any renin inhibitor, or potassium-sparing diuretics. (11) Patients who have experienced serious adverse reactions from the use of mineralocorticoid receptor antagonists (MRAs) in the past. (12) Continuous use of high doses (500 mg/day) of aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) for more than 5 days; (13) Use of potent CYP3A4 inhibitors/inducers or potent CYP2C8 inhibitors (discontinued at least 7 days prior to randomization); (14) Known to be allergic to the investigational drug (active ingredient or excipient); (15) Pregnant, breastfeeding, or planning to become pregnant during the study; (16) Participation in other interventional studies (or other interventional studies that ended within the past month); (17) Patients deemed unsuitable for participation in this study by the researchers. Part 2 (1) Known bilateral clinically significant renal artery stenosis (arterial diameter reduction > 75%); (2) HbA1c > 12%; (3) A history of stroke, transient ischemic attack, acute coronary syndrome, or hospitalization due to worsening heart failure within 30 days prior to screening; pulmonary-related diseases, including exacerbation of asthma, pulmonary embolism, or chronic obstructive pulmonary disease. (4) Active malignant tumors, severe infections, or other significant hematological disorders; history of heart valve replacement or repair surgery; patients with persistent atrial fibrillation. (5) Severe anemia (hemoglobin 5.5 mmol/L) within the past four weeks or prior treatment with potassium-lowering therapy. (9) Cannot discontinue any of the following medications at least 4 weeks prior to screening visits: eplerenone, spironolactone, any renin inhibitor, or potassium-sparing diuretics. (10) Patients who have experienced serious adverse reactions from the use of mineralocorticoid receptor antagonists (MRAs) in the past. (11) Use of potent CYP3A4 inhibitors/induc
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics parameters of finerenone primary metabolites(Part 1);Pharmacodynamic parameters(Part 1);Clearance of finerenone primary metabolites in peritoneal dialysate(Part 1);Clearance of finerenone in peritoneal dialysate(Part 1);?LVMI(Part 2);Pharmacokinetics parameters of finerenone(Part 1); | — |
Secondary
| Measure | Time frame |
|---|---|
| Peritoneal transport capacity(Part 2);Cardiac magnetic resonance parameters (Part 2);Kansas City Cardiomyopathy Questionnaire (KCCQ) score (Part 2);Incidence of adverse events(Part 2);Inflammatory and fibrotic markers in blood (Part 2);Changes in residual kidney function(Part 2);Changes in cardiac function(Part 2);Inflammatory and fibrotic markers in peritoneal dialysate (Part 2);Incidence of adverse events(Part 1);6-minute walk test (Part 2); | — |
Countries
China
Contacts
Public ContactGu Leyi
Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine
Outcome results
None listed