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

Chronic Kidney Disease Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06221059
• Other study ID #: HRS-1780-201
• Status: Recruiting
• Phase: Phase 2
• Start date: March 2, 2024
• Est. completion date: April 2025

Study information

• Verified date: January 2024
• Source: Shandong Suncadia Medicine Co., Ltd.
• Contact: Manchen Bao
• Phone: 0518-82342973
• Email: manchen.bao[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: April 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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

Locations

Country	Name	City	State
China	General Hospital of Eastern Theater Command	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Shandong Suncadia Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to Week 13 in UACR		From Baseline to Week 13
Secondary	Change From Baseline to Week 13 in UACR category (>20%, >30%, >40%)		From Baseline to Week 13
Secondary	Change From Baseline to Week 4, Week 7 in UACR		From Baseline to Week 4, Week 7
Secondary	Change From Baseline to Week 13 in 24-hour urinary protein quantification		From Baseline to Week 13
Secondary	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.		From Baseline to Week 13
Secondary	Change From Baseline to Week 13 in blood pressure		From Baseline to Week 13