type 2 diabetes and chronic kidney disease
Conditions
Interventions
Study Intervention:Finerenone was administered at a dose of 10 mg once-daily oral treatment
Control group:Placebo, in addition to usual therapy
Sponsors
Shanghai Sixth People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Male or female aged 18 years or older at the time of informed consent 2. Clinical diagnosis of T2D (World Health Organization diagnostic criteria) 3. Clinical diagnosis of CKD and meeting both of the following criteria:eGFR (CKD-EPI formula) >= 25 mL/min/1.73 m^2 at screening visit; UACR levels between 30 and 5000 mg/g (3.4 to 565 mg/mmol; geometric mean of three measurements) at screening visit. Documentation of elevated albuminuria or proteinuria (either quantitative or semi-quantitative) in the patient's medical record at least 3 months prior to Screening is required. One reassessment of eGFR and/or UACR is permitted during the Screening period. If one of the three UACR measurements is missing but the other two are valid, the two remaining values may be used to assess subject eligibility. 4. Serum potassium <=5.0 mmol/L at Screening visit.One re-assessment is allowed for potassium during the Screening period 5. No treatment with RASi (ACEi, ARB, or renin inhibitors such as Aliskiren) within 8 weeks prior to the Screening visit. 6. Patients may receive SGLT-2i, GLP-1RA, or other therapies to control urinary UACR, but the type and dose should be stable for at least 4 weeks prior to Screening.
Exclusion criteria
Exclusion criteria: 1. T1D, other special types of diabetes, or gestational diabetes. 2. HbA1c levels greater than 11% in patients with T2D. 3. Renal transplant or acute kidney injury requiring dialysis within 24 weeks prior to Screening visit. 4. Hepatic dysfunction (Child-Pugh Class C). 5. Mean blood pressure above 160/100 mmHg or mean systolic blood pressure below 90 mmHg at the Screening visit. 6. Known hypersensitivity to the study drug (active substance or excipients). 7. Has been treated with finerenone within 8 weeks prior to Screening. 8. Hospitalization for a cardiovascular event (heart failure decompensation, acute coronary syndrome, stroke, transient ischemic attack, acute limb ischemia) within 24 weeks prior to the Screening visit. 9. Symptomatic heart failure with reduced ejection fraction with class 1A indication for MRAs. 10. Addison 's disease. 11. Any other history, condition, therapy or uncontrolled intercurrent illness which would make the participant unsuitable for this study and will not allow participation for the full planned study period (e.g., active malignancy or other condition limiting life expectancy to less than 12 months). 12. Concomitantly treated with strong CYP3A4 inhibitors which cannot be discontinued and have not stopped at least 7 days prior to randomization. 13. The use of other mineralocorticoid receptor antagonists (MRA), angiotensin receptor neprilysin inhibitors (ARNI), or potassium-sparing diuretics must not have been stopped and is not discontinued for at least 8 weeks prior to the Screening visit. 14. History of immunosuppressive therapy within the last 24 weeks, and use of corticosteroids other than topical or inhaled forms. 15. Concurrent participation in another interventional clinical study (e.g., phase 1 to 3 clinical studies) or use of any investigational product within 12 weeks prior to randomization. 16. History of alcohol and / or illicit drug abuse. 17. Female of childbearing potential who are pregnant, breast-feeding, or willing to become pregnant during the trial and not using adequate contraception. 18. Other conditions judged by the investigator as inappropriate for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in UACR from baseline (geometric mean ratio to baseline) over 6 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with: TEAEs, TESAEs; Hyperkalemia (AESI); | — |
Countries
China
Contacts
Public ContactJia Weiping
Shanghai Sixth People's Hospital
Outcome results
None listed