| Trial ID: | L0157 |
| Source ID: | NCT06221059
|
| Associated Drug: |
Hrs-1780 Tablet；Henagliflozin Proline Tablet；Hrs-1780 Tablet Placebo ；Henagliflozin Proline Tablet Placebo
|
| Title: |
Efficacy and Safety of HRS-1780 Tablets and Henagliflozin Proline Tablets in Patients With Chronic Kidney Disease
|
| Acronym: |
|
| Status: |
ACTIVE_NOT_RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Kidney Disease
|
| Interventions: |
DRUG: HRS-1780 tablet；Henagliflozin Proline tablet；HRS-1780 tablet placebo ；Henagliflozin Proline tablet placebo
|
| Outcome Measures: |
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|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
|
| Sponsor/Collaborators: |
Sponsor: Shandong Suncadia Medicine Co., Ltd.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
181
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2024-03-02
|
| Completion Date: |
2025-06
|
| Results First Posted: |
|
| Last Update Posted: |
2025-03-20
|
| Locations: |
General Hospital of Eastern Theater Command, Nanjing, Jiangsu, 210002, China
|
| URL: |
https://clinicaltrials.gov/show/NCT06221059
|
