| Trial ID: | L1731 |
| Source ID: | NCT06720025
|
| Associated Drug: |
Sal-0951 Tablets
|
| Title: |
Study of SAL-0951 Compared to Recombinant Human Erythropoietin in Anemic Patients Receiving Maintenance Hemodialysis
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Anemia
|
| Interventions: |
DRUG: SAL-0951 tablets|DRUG: rHuEPO injection
|
| Outcome Measures: |
Primary: Difference in mean hemoglobin (Hb) level between arms during the evaluation period after treatment (non-inferiority margin: -10 g/L), Hb levels during the evaluation period after treatment are defined as the mean value of Hb levels at weeks 20, 22, and 24., weeks 20, 22, and 24 |
|
| Sponsor/Collaborators: |
Sponsor: Shenzhen Salubris Pharmaceuticals Co., Ltd.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
100
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2023-09-19
|
| Completion Date: |
2024-06-20
|
| Results First Posted: |
|
| Last Update Posted: |
2024-12-06
|
| Locations: |
The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, 510062, China
|
| URL: |
https://clinicaltrials.gov/show/NCT06720025
|
