Chronic Kidney Disease Stage 4Phase 4NCT07027774
Effect of Henagliflozin on Renal Outcomes in Non-dialysis Patients With Advanced Chronic Kidney Disease : A Multicenter Prospective, Randomized Controlled Trial（HERO -aCKD）
A Phase 4 study testing Henagliflozin 5 mg Group, Henagliflozin 10 mg Group and Conventional therapy group in people with Chronic Kidney Disease Stage 4, run by First Affiliated Hospital of Wannan Medical College.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease Stage 4
- What is being tested?
- Henagliflozin 5 mg Group, Henagliflozin 10 mg Group and Conventional therapy group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 429 participants
- Where
- No sites listed yet
- Study dates
- 10 Jul 2025to 30 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The investigator considers that the participant does not require Henagliflozin or any other SGLT-2 inhibitor therapy, nor deems such therapy absolutely inappropriate; and based on local laboratory results within 6 months before the screening visit and at the screening visit, the following criteria must be met:
- 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;
- Anticipated time to requiring dialysis is greater than 1 month;
- Provision of written informed consent (illiterate participants may use a thumbprint in lieu of a signature).
Who cannot join
- 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;
- ALT or AST levels >3 times the upper limit of normal (ULN) at screening;
- Received any intravenous immunosuppressive therapy within the previous 3 months; or any subject who received prednisone >45 mg/day (or equivalent dose) within the previous 3 months;
Show all 17Show fewer
- Current use or use within 12 weeks prior to enrollment of glucagon-like peptide-1 (GLP-1) receptor agonist medications (e.g., liraglutide, semaglutide, dulaglutide, etc.) or current participation in another clinical trial of glucose-lowering drugs that may affect kidney or cardiovascular outcomes;(9) Severe malnutrition (serum albumin <25 g/L) and/or severe anemia (hemoglobin <70 g/L);
- Known poor adherence to clinical follow-up or medication;
- Myocardial infarction, unstable angina, or stroke within 12 weeks prior to enrollment;
- Underwent coronary revascularization (percutaneous coronary intervention [PCI] or coronary artery bypass grafting [CABG]) or valve repair/replacement within 12 weeks prior to enrollment, or plans to undergo any of these procedures after randomization;(13) Any disease other than kidney or cardiovascular disease (e.g., but not limited to, malignancy) that, in the investigator's clinical judgment, is associated with a life expectancy of less than 2 years;
- Active malignancy requiring treatment at the time of the first visit (except for successfully treated basal cell carcinoma, treated squamous cell carcinoma, or thyroid cancer);
- Currently pregnant, breastfeeding, or a woman of childbearing potential (WOCBP) unless using a highly effective method of contraception;
- Type 1 diabetes;(17) Investigator considers the patient unable to understand and/or comply with the study procedures and/or follow-up, or any condition that, in the investigator's opinion, may lead to the patient's inability to complete the study.
- Additionally, subjects will be excluded at the randomization visit if any of the following occur:
- Did not adhere to the run-in treatment;
- No longer willing to be randomized and followed for at least 2 years;
- Considered unsuitable for randomization by the local investigator; OR experienced ketoacidosis, heart attack (myocardial infarction), stroke, hospitalization for heart failure, hospitalization for urinary tract infection, or acute kidney injury during the run-in period.
About this study
Official title: A Multicenter, Prospective, Randomized, Controlled Study Evaluating the Progression of Renal Function in Patients With Late-Stage Chronic Kidney Disease Treated With Henagliflozin
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).
Read more
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.
- Conditions
- Chronic Kidney Disease Stage 4
- Being tested
- Henagliflozin 5 mg Group, Henagliflozin 10 mg Group, Conventional therapy group
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Henagliflozin 5 mg GroupDrug
Henagliflozin 5 mg once daily plus KDIGO-based comprehensive management strategy (e.g., RAAS inhibitors）
Henagliflozin 10 mg GroupDrug
Henagliflozin 10 mg once daily plus KDIGO-based comprehensive management strategy (e.g., RAAS inhibitors）
Conventional therapy groupDrug
KDIGO-based comprehensive management strategy (e.g., RAAS inhibitors）
| Study group | Role | What they receive |
|---|---|---|
| Henagliflozin 5mg Group | Experimental | Henagliflozin 5 mg once daily + RAASi-based comprehensive strategy (optional) Receives: Drug: Henagliflozin 5 mg Group |
| Henagliflozin 10mg Group | Experimental | Henagliflozin 10 mg once daily + RAASi-based comprehensive strategy (optional) Receives: Drug: Henagliflozin 10 mg Group |
| Conventional therapy group | Active comparator | RAASi-based comprehensive strategy (e.g., ramipril + lipid control + glycemic management) Receives: Drug: Conventional therapy group |
What is being measured
The primary outcome is the main question the study is designed to answer.
eGFR total slope change from 4 to 52 weeks
Measured: 52 weeks
Secondary outcomes (9)
Total eGFR slope at 1 year post-randomization
Measured: 56 weeks
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.
Measured: 56 weeks
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.
Measured: 56 weeks
Composite endpoint of major adverse cardiovascular events (MACE) (defined as cardiovascular death, myocardial infarction, stroke, or hospitalization for heart failure)
Measured: 56 weeks
Composite endpoint of initiation of maintenance dialysis or kidney transplantation, kidney death, or cardiovascular death.
Measured: 56 weeks
Composite endpoint of initiation of maintenance dialysis, kidney transplantation, or kidney death.
Measured: 56 weeks
Composite endpoint of cardiovascular death, myocardial infarction, stroke, hospitalization for heart failure, or unstable angina.
Measured: 56 weeks
Cardiovascular death or hospitalization for heart failure.
Measured: 56 weeks
All-cause hospitalization
Measured: 56 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2025
- Study start10 Jul 2025 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease Stage 4Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 429 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Wannan Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07027774
- Sponsor's protocol ID
- FAW2024104
- Status last verified
- Jun 2025
- First submitted
- 10 Jun 2025
- Last updated
- 18 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Randomized, Controlled Study Evaluating the Progression of Renal Function in Patients With Late-Stage Chronic Kidney Disease Treated With Henagliflozin
- ClinicalTrials.gov ID
- NCT07027774
- Acronym / sponsor ID
- FAW2024104
- Conditions
- Chronic Kidney Disease Stage 4
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 429 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Wannan Medical CollegeUniversity, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Study start
- 10 Jul 2025 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 18 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Henagliflozin 5mg Group | Experimental | Drug: Henagliflozin 5 mg GroupHenagliflozin 5 mg once daily + RAASi-based comprehensive strategy (optional) |
| Henagliflozin 10mg Group | Experimental | Drug: Henagliflozin 10 mg GroupHenagliflozin 10 mg once daily + RAASi-based comprehensive strategy (optional) |
| Conventional therapy group | Active comparator | Drug: Conventional therapy groupRAASi-based comprehensive strategy (e.g., ramipril + lipid control + glycemic management) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The investigator considers that the participant does not require Henagliflozin or any other SGLT-2 inhibitor therapy, nor deems such therapy absolutely inappropriate; and based on local laboratory results within 6 months before the screening visit and at the screening visit, the following criteria must be met:
- 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;
- Anticipated time to requiring dialysis is greater than 1 month;
- Provision of written informed consent (illiterate participants may use a thumbprint in lieu of a signature).
Key exclusion criteria (17 listed)
- 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;
- ALT or AST levels >3 times the upper limit of normal (ULN) at screening;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Henagliflozin 5 mg GroupHenagliflozin 5 mg once daily plus KDIGO-based comprehensive management strategy (e.g., RAAS inhibitors） | Drug | Henagliflozin 5mg Group |
| Henagliflozin 10 mg GroupHenagliflozin 10 mg once daily plus KDIGO-based comprehensive management strategy (e.g., RAAS inhibitors） | Drug | Henagliflozin 10mg Group |
| Conventional therapy groupKDIGO-based comprehensive management strategy (e.g., RAAS inhibitors） | Drug | Conventional therapy group |
Primary outcome
eGFR total slope change from 4 to 52 weeks
Time frame: 52 weeks
9 secondary outcomes
Total eGFR slope at 1 year post-randomization
Time frame: 56 weeks
Composite endpoint of kidney disease progression ，hospitalization for heart failure, or cardiovascular death.
Time frame: 56 weeks
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).
Time frame: 56 weeks
Composite endpoint of major adverse cardiovascular events (MACE) (defined as cardiovascular death, myocardial infarction, stroke, or hospitalization for heart failure)
Time frame: 56 weeks
Composite endpoint of initiation of maintenance dialysis or kidney transplantation, kidney death, or cardiovascular death.
Time frame: 56 weeks
Composite endpoint of initiation of maintenance dialysis, kidney transplantation, or kidney death.
Time frame: 56 weeks
Composite endpoint of cardiovascular death, myocardial infarction, stroke, hospitalization for heart failure, or unstable angina.
Time frame: 56 weeks
Cardiovascular death or hospitalization for heart failure.
Time frame: 56 weeks
All-cause hospitalization
Time frame: 56 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Henagliflozin 5 mg Group, Henagliflozin 10 mg Group and Conventional therapy group in people with Chronic Kidney Disease Stage 4, run by First Affiliated Hospital of Wannan Medical College.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
eGFR total slope change from 4 to 52 weeks (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2025.