This is a multicenter, prospective, randomized, controlled study that will enroll approximately 429 subjects. The screening period will last 4-8 weeks. Subjects will undergo pre-screening based on eGFR and urinary albumin-to-creatinine ratio (UACR). Only non-dialysis subjects meeting the following criteria confirmed by local laboratories within 6 months prior to screening will be eligible for central laboratory screening:
10 mL/min/1.73m² ≤ eGFR \< 30 mL/min/1.73m² and 150 mg/g (16.95 mg/mmol) ≤ UACR \< 5000 mg/g (565 mg/mmol).
Unless contraindicated due to intolerance, subjects with 20 mL/min/1.73m² ≤ eGFR \< 30 mL/min/1.73m² must receive stable, maximally tolerated labeled daily doses of ACEi or ARB for at least 4 weeks prior to randomization. For subjects with 10 mL/min/1.73m² ≤ eGFR \< 20 mL/min/1.73m², investigators will determine ACEi/ARB treatment based on patient condition per KDIGO guidelines. Other antihypertensive, lipid-lowering, and glucose-lowering therapies should be stabilized for approximately 4 weeks before randomization. Investigators are encouraged to maintain stability of medications known to affect serum creatinine levels during screening and approximately 2 weeks prior to any serum chemistry measurements throughout the study. Eligible subjects will be randomized in a 1:1:1 ratio to receive Henagliflozin (10 mg q.d., 5 mg q.d.) or conventional therapy.
Thereafter, subjects will undergo laboratory assessments, concomitant medication review, adverse event collection, and clinical endpoint ascertainment at Week 4 (Day 30), Week 12 (Day 90), and Week 24 (Day 180), followed by every 12-week intervals. Throughout the study, all subjects will receive glycemic, blood pressure (target SBP \<140 mmHg and DBP \<90 mmHg), and lipid management according to current guidelines. All subjects will complete an end-of-study visit. Subjects discontinuing study drug prematurely should continue all subsequent study visits.
10 mL/min/1.73m² ≤ eGFR < 30 mL/min/1.73m² (CKD-EPI equation), and
150 mg/g (16.95 mg/mmol) ≤ Urine Albumin-to-Creatinine Ratio (UACR) < 5000 mg/g (565 mg/mmol)
Age ≥ 18 years, male or femal
Participants with 20 mL/min/1.73m² ≤ eGFR < 30 mL/min/1.73m² must be on a stable and tolerated dose of an ACE inhibitor (ACEI) or ARB for at least 4 weeks, unless intolerant (reasons for intolerance must be documented). Participants with 10 mL/min/1.73m² ≤ eGFR < 20 mL/min/1.73m² should have ACEI/ARB use determined by the investigator based on the patient's clinical status and KDIGO guideline recommendations;
Received SGLT2 inhibitor treatment within 8 weeks prior to enrollment or with a history of SGLT2 inhibitor intolerance;
Receiving combined therapy with an ACE inhibitor (ACEi) and an ARB, or a renin inhibitor combined with ACEi or ARB (based on self-report at screening and randomization visits);
On maintenance dialysis, has a functioning kidney transplant, or is a planned living donor transplant recipient (based on self-report at screening and randomization visits);
Polycystic kidney disease, active lupus nephritis, or systemic vasculitis;(5) Symptomatic hypotension, or systolic blood pressure <90 mmHg or >180 mmHg at screening;
Parallel
Henagliflozin 5 mg Group
DrugHenagliflozin 5 mg once daily plus KDIGO-based comprehensive management strategy (e.g., RAAS inhibitors）
Henagliflozin 10 mg Group
DrugHenagliflozin 10 mg once daily plus KDIGO-based comprehensive management strategy (e.g., RAAS inhibitors）
Conventional therapy group
DrugKDIGO-based comprehensive management strategy (e.g., RAAS inhibitors）
eGFR total slope change from 4 to 52 weeks
Total eGFR slope at 1 year post-randomization
Composite endpoint of kidney disease progression ，hospitalization for heart failure, or cardiovascular death.
Composite endpoint of kidney disease progression (defined as a sustained decline in eGFR of ≥40% from baseline, sustained eGFR \<7.5 mL/min/1.73m², initiation of maintenance dialysis or kidney transplantation, or kidney death), hospitalization for heart failure, or cardiovascular death.
Kidney disease progression (sustained eGFR decline ≥40%, sustained eGFR <7.5 mL/min/1.73m², initiation of maintenance dialysis or kidney transplantation, or kidney death).
Kidney disease progression is defined as a sustained decline in eGFR of ≥40% from baseline since randomization, sustained decline in eGFR to \<7.5 mL/min/1.73m², initiation of maintenance dialysis or kidney transplantation, or death due to kidney disease.
Composite endpoint of major adverse cardiovascular events (MACE) (defined as cardiovascular death, myocardial infarction, stroke, or hospitalization for heart failure)
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First Affiliated Hospital of Wannan Medical College
Lead sponsor
Jiangsu HengRui Medicine Co., Ltd.
Collaborator
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