Efficacy and Safety of HRS-1780 Tablets and Henagliflozin Proline Tablets in Patients With Chronic Kidney Disease

Shandong Suncadia Medicine

Status and phase: Completed; Phase 2

Conditions: Chronic Kidney Disease

Treatments: Drug: HRS-1780 tablet；Henagliflozin Proline tablet；HRS-1780 tablet placebo ；Henagliflozin Proline tablet placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06221059

HRS-1780-201

Details and patient eligibility

About

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

Enrollment: 181 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Men and women aged 18-75 years old
2. Body mass index (BMI) ≥18.0 and <50.0 kg/m2 at the screening visit
3. 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
4. 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
5. 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
6. HbA1c <9.0% at the screening visit

Exclusion criteria

1. A known or suspected allergy to the investigational drug or its components or excipients;
2. Receive a potent inhibitor/inducer of cytochrome P450 3A4 (CYP3A4) within 7 days prior to screening;
3. 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;
4. Receive SGLT-2 or SGLT-1/2 inhibitors within 4 weeks before screening
5. Received glucagon-like peptide-1 receptor agonist (GLP-1RA) within 8 weeks before screening
6. Received systemic glucocorticoid therapy within 3 months before screening
7. Received immunosuppressive drugs or biological agents
8. Received any other study drug treatment within 3 months or 5 half-lives prior to screening
9. 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
10. 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
11. Diagnosed or suspected polycystic kidney disease, lupus nephritis, anti-neutrophil cytoplasmic antibody (ANCA) -associated vasculitis, acute glomerulonephritis, bilateral renal artery stenosis;
12. Acute kidney injury or dialysis treatment within 6 months before screening
13. Received kidney transplant, or plan to receive kidney transplant during the trial

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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181 participants in 4 patient groups, including a placebo group

HRS-1780 dose 1

Experimental group

Treatment:

Drug: HRS-1780 tablet；Henagliflozin Proline tablet；HRS-1780 tablet placebo ；Henagliflozin Proline tablet placebo

HRS-1780 dose 2

Experimental group

Treatment:

Drug: HRS-1780 tablet；Henagliflozin Proline tablet；HRS-1780 tablet placebo ；Henagliflozin Proline tablet placebo

Henagliflozin Proline

Active Comparator group

Treatment:

Drug: HRS-1780 tablet；Henagliflozin Proline tablet；HRS-1780 tablet placebo ；Henagliflozin Proline tablet placebo

Placebo

Placebo Comparator group

Treatment:

Drug: HRS-1780 tablet；Henagliflozin Proline tablet；HRS-1780 tablet placebo ；Henagliflozin Proline tablet placebo