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

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)

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

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease
• Intervention / Treatment: Drug: HRS-1780 tablet；Henagliflozin Proline tablet；HRS-1780 tablet placebo ；Henagliflozin Proline tablet placebo

• Study Type: Interventional
• Enrollment (Actual): 181
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210002
      • General Hospital of Eastern Theater Command

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	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
Experimental: HRS-1780 dose 1	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
Experimental: HRS-1780 dose 2	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
Active Comparator: Henagliflozin Proline	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change From Baseline to Week 13 in UACR	From Baseline to Week 13

Secondary Outcome Measures

Outcome Measure	Time Frame
Change From Baseline to Week 13 in UACR category （>20%, >30%, >40%)	From Baseline to Week 13
Change From Baseline to Week 4, Week 7 in UACR	From Baseline to Week 4, Week 7
Change From Baseline to Week 13 in 24-hour urinary protein quantification	From Baseline to Week 13
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
Change From Baseline to Week 13 in blood pressure	From Baseline to Week 13

Collaborators and Investigators

• Sponsor: Shandong Suncadia Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2024
• Primary Completion (Actual): March 5, 2025
• Study Completion (Actual): June 24, 2025

Study Registration Dates

• First Submitted: January 14, 2024
• First Submitted That Met QC Criteria: January 14, 2024
• First Posted (Actual): January 24, 2024

Study Record Updates

• Last Update Posted (Actual): December 1, 2025
• Last Update Submitted That Met QC Criteria: November 26, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic
• Other Study ID Numbers: HRS-1780-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No