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

NCT06221059 | Completed Phase 2

• 1 other identifier: HRS-1780-201
• Study Type: interventional
• Target: 181
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Week 13 in UACR

  From Baseline to Week 13

Secondary Outcomes (5)

• 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

Study Arms (4)

HRS-1780 dose 1

EXPERIMENTAL

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

HRS-1780 dose 2

EXPERIMENTAL

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

Henagliflozin Proline

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Interventions

HRS-1780 tablet；Henagliflozin Proline tablet；HRS-1780 tablet placebo ；Henagliflozin Proline tablet placebo DRUG

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

HRS-1780 dose 1; HRS-1780 dose 2; Henagliflozin Proline; Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shandong Suncadia Medicine Co., Ltd.: lead

Study Sites (1)

General Hospital of Eastern Theater Command

Nanjing, Jiangsu, 210002, China

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2024
• First Posted: January 24, 2024
• Study Start: March 2, 2024
• Primary Completion: March 5, 2025
• Study Completion: June 24, 2025
• Last Updated: December 1, 2025

Record last verified: 2025-03

Locations

CN (1)