| Trial ID: | L1069 |
| Source ID: | NCT06016036
|
| Associated Drug: |
Sal-0951
|
| Title: |
SAL-0951 Tablets in the Treatment of Renal Anemia in Non-dialysis Chronic Kidney Disease
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Renal Anemia in Non-dialysis Chronic Kidney Disease
|
| Interventions: |
DRUG: SAL-0951|DRUG: Placebo
|
| Outcome Measures: |
Primary: Difference in mean Hb concentration levels from baseline at weeks 7-9, Change From Baseline in mean Hb concentration levels at week 7-9, Baseline and week 7-9 | Secondary: double-blind phase：The cumulative percentage of subjects who achieved Hb response at any time from treatment to week 9, Change From Baseline in cumulative percentage of subjects who achieved Hb response at any time at week 9, Baseline to week 9|Double-blind phase：Proportion of subjects with average Hb level ≥100 g/L at week 7-9, Week 7-9|Double-blind phase：Proportion of average Hb concentration ≥100g/L and ≤120g/L in week 9, Week 9|Double-blind phase：By week 9, the cumulative proportion of subjects whose Hb increased by ≥10 g/L and whose Hb reached ≥100g/L, Week 9|Double-blind phase：By week 9, the cumulative proportion of Hb > 130 g/L, Week 9|Double-blind phase：Proportion of subjects receiving intravenous iron at week 9, Week 9
|
| Sponsor/Collaborators: |
Sponsor: Shenzhen Salubris Pharmaceuticals Co., Ltd.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
156
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2020-12-08
|
| Completion Date: |
2022-02-21
|
| Results First Posted: |
|
| Last Update Posted: |
2024-08-13
|
| Locations: |
Guangdong Provincial People's Hospital, Guangzhou, Guangdong, 519041, China
|
| URL: |
https://clinicaltrials.gov/show/NCT06016036
|
