T2DM combined with CKD
Conditions
Interventions
SGLT-2i Group:Henagliflozin Proline
SGLT-2i+finerenone Group:Henagliflozin Proline plus finerenone
Sponsors
The first medical center of Chinese PLA general hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Subjects must be aged >= 18 years and <80 years at the screening visit. Patients clinically diagnosed with CKD who meet the following criteria: eGFR of 45-90 mL/min/1.73m² at the screening visit, calculated using the CKD-EPI formula. Documentation of albuminuria/proteinuria (quantitative or semi-quantitative measurement) in the subject's medical records at the screening visit and for at least 3 months prior, showing 30 < UACR < 5000 mg/g. Patients with T2D as defined by the ADA Standards of Medical Care in Diabetes (2025), with a glycated hemoglobin (HbA1c) <11% at screening. Note: Historical HbA1c values obtained within 3 months before the screening visit may be used. At the screening visit, subjects must be on the clinically maximum tolerated dose of ACEi or ARB for more than 1 month as judged by the investigator, but not concurrently receiving both treatments. Male or female Female subjects must use contraception in accordance with local regulations regarding contraceptive methods for clinical research participation. Female subjects: Women of childbearing potential (WOCBP) may only be included if they have a negative pregnancy test at the screening visit and agree to use adequate contraception during the study and for 8 weeks after the last dose of the study intervention. Adequate contraception is defined as the use of at least two effective birth control methods in any combination, with at least one being a physical barrier (e.g., condom with hormonal contraceptives or implants, combined oral contraceptives, certain intrauterine devices). Postmenopausal women do not require contraception. Elevated follicle-stimulating hormone (FSH) levels within the postmenopausal range may be used to confirm postmenopausal status, in which case hormonal contraceptives or hormone replacement therapy (HRT) are not required. However, in the absence of 12 months of amenorrhea, confirmation via multiple FSH measurements is needed. Women receiving HRT whose menopausal status is uncertain and who wish to continue HRT during the study must use at least one non-estrogen-based highly effective contraceptive method. Otherwise, they must discontinue HRT to confirm postmenopausal status before study enrollment. Women without childbearing potential (documented hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) do not require contraception. Women with permanent infertility due to other medical reasons (e.g., Müllerian agenesis, androgen insensitivity) may be enrolled at the investigator's discretion. Capable of providing signed informed consent (ICF), including compliance with the requirements and restrictions listed in the ICF and this protocol.
Exclusion criteria
Exclusion criteria: Medical Conditions Subjects with type 1 diabetes (T1D). Subjects with a known allergy to finerenone or any SGLT-2 inhibitor. Subjects with hepatic insufficiency classified as Child-Pugh C. Subjects with blood pressure >160 mmHg systolic (SBP) or >100 mmHg diastolic (DBP), or SBP 75%) or biopsy-confirmed non-diabetic kidney disease. Subjects with a functioning renal allograft or planned kidney transplantation. Subjects with acute kidney injury (AKI) within 6 months before screening. Subjects with a history of diabetic ketoacidosis in the past 5 years. Subjects with primary adrenal insufficiency (Addison’s disease). Subjects with a history of stroke, transient ischemic attack (TIA), acute coronary syndrome (MI, CABG, major PCI), or hospitalization for worsening heart failure (HF) within 90 days before screening. Subjects with chronic heart failure with reduced ejection fraction (HFrEF) and persistent symptoms (NYHA Class II-IV) at screening (where MRA is a Class 1A recommendation). Subjects who have undergone major surgery within 90 days before screening (as assessed by the investigator) or planned major elective surgery (e.g., hip replacement) within 90 days after screening. Subjects with prior gastrointestinal surgery or gastrointestinal disorders that, in the investigator’s opinion, may interfere with study drug absorption. Any other medical history, condition, treatment, or uncontrolled concurrent illness (including AKI) that, in the investigator’s judgment, may compromise the subject’s safety or compliance with study requirements. Prior/Concomitant Therapy Subjects currently on SGLT-2 inhibitor therapy or who have received SGLT-2 inhibitors within 8 weeks before screening and cannot discontinue treatment during the study intervention period. Subjects receiving strong CYP3A4 inhibitors or inducers that cannot be discontinued 7 days before Visit 2 (Day 1) (see Appendix 8). Subjects receiving another MRA (e.g., eplerenone, esaxerenone, spironolactone, canrenone), renin inhibitors, potassium (K+) supplements, potassium-sparing diuretics (e.g., amiloride, triamterene), K+ binders, or ARNIs within 8 weeks before screening or during the study intervention period. Subjects currently taking or having taken finerenone (Kerendia®) within 8 weeks before screening. Prior/Concurrent Clinical Study Experience Subjects who have participated in another investigational drug study within 1 month before screening. Diagnostic Assessments Subjects with serum potassium (K+) >4.8 mmol/L at screening. Note: One repeat K+ measurement is allowed at screening. Subjects with ALT or AST >3× upper limit of normal (ULN) at screening. Other Exclusion Criteria Breastfeeding female subjects. Subjects with a known history of non-compliance with outpatient visits or prescribed medication use.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| UACR;serum potassium; | — |
Secondary
| Measure | Time frame |
|---|---|
| blood creatinine; | — |
Countries
China
Contacts
Public ContactWeijun Gu
The first medical center of Chinese PLA general hospital
Outcome results
None listed