Status:
COMPLETED
Efficacy and Safety of HRS-1780 Tablets and Henagliflozin Proline Tablets in Patients With Chronic Kidney Disease
Lead Sponsor:
Shandong Suncadia Medicine Co., Ltd.
Conditions:
Chronic Kidney Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The objective of this study was to evaluate the efficacy of HRS-1780 tablets or Henagliflozin Proline tablets in patients with chronic kidney disease by evaluating UACR change from baseline to Week 13
Eligibility Criteria
Inclusion
- Men and women aged 18-75 years old
- Body mass index (BMI) ≥18.0 and \<50.0 kg/m2 at the screening visit
- Subjects treated with an angiotensin-converting enzyme inhibitor (ACEI) and/or angiotensin receptor blocker (ARB) for at least 3 months without any adjustments to this therapy for at least 4 weeks prior to the screening visit
- Diagnosed with chronic kidney disease, and the estimated glomerular filtration rate (eGFR) was ≥30 and \<90 mL/min/1.73 m2 calculated using the CKD-EPI formula at the screening visit
- Urinary albumin/creatinine ratio (UACR) was ≥300 and \<3000 mg/g for at least 2 times on different days detected by the local laboratory; at the screening visit
- HbA1c \<9.0% at the screening visit
Exclusion
- A known or suspected allergy to the investigational drug or its components or excipients;
- Receive a potent inhibitor/inducer of cytochrome P450 3A4 (CYP3A4) within 7 days prior to screening;
- Within 4 weeks before screening, the following drugs could not maintain the stable regimen: diabetes drugs, hypertension drugs, non-steroidal anti-inflammatory drugs, endothelin receptor antagonists;
- Receive SGLT-2 or SGLT-1/2 inhibitors within 4 weeks before screening
- Received glucagon-like peptide-1 receptor agonist (GLP-1RA) within 8 weeks before screening
- Received systemic glucocorticoid therapy within 3 months before screening
- Received immunosuppressive drugs or biological agents
- Received any other study drug treatment within 3 months or 5 half-lives prior to screening
- Severe hypertension that was not controlled at screening visit or random visit (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg), or systolic blood pressure \<90 mmHg
- Have urinary tract infection or/and genital infection at the screening visit or random visit, or have a history of repeated urinary tract infection or/and genital infection
- Diagnosed or suspected polycystic kidney disease, lupus nephritis, anti-neutrophil cytoplasmic antibody (ANCA) -associated vasculitis, acute glomerulonephritis, bilateral renal artery stenosis;
- Acute kidney injury or dialysis treatment within 6 months before screening
- Received kidney transplant, or plan to receive kidney transplant during the trial
Key Trial Info
Start Date :
March 2 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 24 2025
Estimated Enrollment :
181 Patients enrolled
Trial Details
Trial ID
NCT06221059
Start Date
March 2 2024
End Date
June 24 2025
Last Update
December 1 2025
Active Locations (1)
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1
General Hospital of Eastern Theater Command
Nanjing, Jiangsu, China, 210002