| Trial ID: | L1634 |
| Source ID: | NCT06747247
|
| Associated Drug: |
Mt1013
|
| Title: |
MT1013 Injection for the Treatment of Patients With Secondary Hyperparathyroidism (SHPT) Undergoing Maintenance Dialysis
|
| Acronym: |
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| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Secondary Hyperparathyroidism (SHPT) in Subjects With Chronic Kidney Disease (CKD) on Hemodialysis
|
| Interventions: |
DRUG: MT1013|DRUG: Placebo
|
| Outcome Measures: |
Primary: SAD/MAD Studies: treatment-emergent adverse events (TEAEs), SAD arm: All patients receive a single dose of MT1013/Placebo after dialysis. MAD arm：All patients receive MT1013/Placebo three times a week after dialysis for a total of 2 or 4 weeks., SAD：8 days. MAD：2- 4weeks (+7 days)|Single Arm MT1013 Long Term Treatment Study: Proportion of subjects with > 30% reduction in iPTH compared to baseline level., 14 weeks | Secondary: Proportion of subjects with > 30% reduction in iPTH compared to baseline level at evaluated timepoints., SAD: 8 days. MAD: 2-4 weeks (+7 days). Single Arm: 52 weeks|Change from baseline in mean serum iPTH levels at evaluated timepoints., SAD: 8 days. MAD: 2-4 weeks (+7 days). Single Arm: 52 weeks|Change from baseline in corrected Ca levels at evaluated timepoints., SAD: 8 days. MAD: 2-4 weeks (+7 days). Single Arm: 52 weeks
|
| Sponsor/Collaborators: |
Sponsor: Shaanxi Micot Technology Limited Company
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
102
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2023-04-12
|
| Completion Date: |
2025-08-30
|
| Results First Posted: |
|
| Last Update Posted: |
2024-12-24
|
| Locations: |
First Affiliated Hospital College of Medicine, Zhejiang University, Hangzhou, Zhejiang, 310003, China
|
| URL: |
https://clinicaltrials.gov/show/NCT06747247
|
