Clinical trial NCT06221059: Efficacy and Safety of HRS-1780 Tablets and Henagliflozin Proline Tablets in Patients With Chronic Kidney Disease
Official title: A Phase II Clinical Study of Efficacy and Safety of HRS-1780 Tablets and Henagliflozin Proline Tablets in the Treatment of Patients With Chronic Kidney Disease (Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Design)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Chronic Kidney Disease
Lead sponsor: Shandong Suncadia Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-01-24
Enrollment: 181
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Change From Baseline to Week 13 in UACR
timeFrame: From Baseline to Week 13
Secondary outcomes:
measure: Change From Baseline to Week 13 in UACR category （>20%, >30%, >40%)
timeFrame: From Baseline to Week 13
measure: Change From Baseline to Week 4, Week 7 in UACR
timeFrame: From Baseline to Week 4, Week 7
measure: Change From Baseline to Week 13 in 24-hour urinary protein quantification
timeFrame: From Baseline to Week 13
measure: Change From Baseline to Week 13 in estimated glomerular filtration rate (eGFR). An eGFR was calculated based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.
timeFrame: From Baseline to Week 13
measure: Change From Baseline to Week 13 in blood pressure
timeFrame: From Baseline to Week 13
Other outcomes:
Locations:
city: Nanjing
country: China
facility: General Hospital of Eastern Theater Command
state: Jiangsu
Study officials:
References: