| Trial ID: | L1638 |
| Source ID: | NCT06236295
|
| Associated Drug: |
Shr6508
|
| Title: |
Investigating the Safety and Efficacy of SHR6508 Injection in the Treatment of Secondary Hyperparathyroidism in Hemodialysis Patients : A Multicenter, Long-term Clinical Trial
|
| Acronym: |
|
| Status: |
ACTIVE_NOT_RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Secondary Hyperparathyroidism (SHPT) in Subjects With Chronic Kidney Disease (CKD) on Hemodialysis
|
| Interventions: |
DRUG: SHR6508
|
| Outcome Measures: |
Primary: Incidence and severity of any adverse events that occurred during the clinical study, through study completion, an average of 1 year | Secondary: Percent change from baseline in predialysis iPTH during the EAP, through study completion, an average of 1 year|Percent change from baseline in predialysis serum cCa during the EAP, through study completion, an average of 1 year|Percent change from baseline in predialysis serum phosphorus during the EAP, through study completion, an average of 1 year|Percent change from baseline in predialysis calcium-phosphorus product during the EAP, through study completion, an average of 1 year
|
| Sponsor/Collaborators: |
Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
303
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2024-02-20
|
| Completion Date: |
2025-12
|
| Results First Posted: |
|
| Last Update Posted: |
2024-07-10
|
| Locations: |
Peking University People's Hospital, Beijing, Beijing, 100044, China
|
| URL: |
https://clinicaltrials.gov/show/NCT06236295
|
