Overview

Effect of Henagliflozin on Renal Outcomes in Non-dialysis Patients With Advanced Chronic Kidney Disease : A Multicenter Prospective, Randomized Controlled TrialHERO -aCKD

Status:
NOT_YET_RECRUITING

Trial end date:
2027-12-30

Target enrollment:

Participant gender:

Summary

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/1.73m eGFR \< 30 mL/min/1.73m 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/1.73m eGFR \< 30 mL/min/1.73m 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/1.73m eGFR \< 20 mL/min/1.73m, 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.

Phase:

PHASE4

Details

Lead Sponsor:

First Affiliated Hospital of Wannan Medical College

Collaborator:

Jiangsu HengRui Medicine Co., Ltd.

Treatments:

henagliflozin
Population Groups