Chronic kidney disease
Conditions
Interventions
Experimental group:Rosuvastatin
Sponsors
Peking University Third Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Understand the research procedures and methods, voluntarily participate in this trial, and sign the informed consent form in writing; 2. Adult subjects aged 18 to 75 years (inclusive), with no less than one-third of each gender; 3. Diagnosed with chronic kidney disease (>3 months), with stable renal function (difference in estimated glomerular filtration rate tests within 3 months prior to enrollment <=30%), estimated glomerular filtration rate (eGFR) <15 mL/min/1.73m², and undergoing peritoneal dialysis for more than 3 months; 4. During the screening period, vital signs and laboratory test indicators are normal or abnormal but stable and controllable, and, in the investigator's judgment, do not affect enrollment.
Exclusion criteria
Exclusion criteria: 1. History of kidney transplantation. 2. Underwent plasmapheresis or major surgery requiring blood transfusion within the past 3 months. 3. Presence of uncontrolled or unstable conditions that affect the function of major metabolic enzymes and transporters (e.g., cancer, acute kidney injury, liver cirrhosis, severe liver impairment, severe fatty liver, liver abscess, intrahepatic bile duct stones, etc.), which are deemed inappropriate for study participation by the investigator. 4. History of fecal microbiota transplantation or received antibiotic treatment within one week prior to screening. 5. Use of probiotics (including yogurt containing probiotics), prebiotics, or synbiotics within one week prior to screening. 6. Use of Vitamin B3 or B6 supplements within one week prior to screening. 7. Smoked an average of more than 5 cigarettes per day within the 3 months prior to screening, or inability to abstain from using any tobacco products during the trial period. 8. Average weekly alcohol consumption exceeding 14 units (1 unit = 17.7 mL ethanol, equivalent to 357 mL of beer [5% alcohol], 43 mL of spirits [40% alcohol], or 147 mL of wine [12% alcohol]) within the 3 months prior to screening, or inability to abstain from alcohol during the trial, or a positive alcohol breath test. 9. History of drug abuse within one year prior to screening. 10. Presence of HIV infection (anti-HIV positive), active hepatitis B (HBsAg positive or HBcAb positive, with a positive HBV-DNA PCR result), or active hepatitis C (Anti-HCV positive with a positive HCV-RNA PCR result), or active syphilis within 6 months prior to screening. 11. Use of medications that may affect the function of major metabolic enzymes and transporters within one week prior to the trial, including: Fluconazole, Fluoxetine, Fluvoxamine, Ticlopidine, Apalutamide, Rifampin, Bupropion, Dacomitinib, Paroxetine, Podophyllin, Quinidine, Boceprevir, Ceritinib, Conivaptan Hydrochloride, Verapamil, Diltiazem, Aprepitant, Dronedarone, Tacrolimus, Cyclosporine, Protease Inhibitors (Ritonavir, Indinavir, Nelfinavir, Saquinavir, Lopinavir), Macrolide antibiotics (Erythromycin, Clarithromycin, Telithromycin), Chloramphenicol, Azole antifungals (Ketoconazole, Itraconazole, Posaconazole, Voriconazole, Fluconazole, Miconazole), Nefazodone, Cobicistat, Cimetidine, Ciprofloxacin, Fluvoxamine, Imatinib, St. John's Wort, Ranolazine, p-Aminohippuric Acid, Probenecid, Teriflunomide, Apalutamide, Ezetimibe, Rifampicin, Carbamazepine, Enzalutamide, Ivosidenib, Mitotane, Phenytoin, Hypericum perforatum (St. John's Wort). 12. History of severe hypersensitivity, intolerance, or allergic reaction to the investigational drugs (including Rosuvastatin and Furosemide), unless approved by the investigator (or designee). 13. Any medical or psychological condition that, in the opinion of the investigator, may increase the risk associated with study participation or render the patient unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rosuvastatin plasma concentration;Furosemide plasma concentration; | — |
Countries
China
Contacts
Public ContactWeng Tang
Peking University Third Hospital
Outcome results
None listed