| Trial ID: | L1466 |
| Source ID: | NCT06690242
|
| Associated Drug: |
Mt1013
|
| Title: |
MT1013 Injection for the Treatment of Secondary Hyperparathyroidism in Patients with Chronic Kidney Disease
|
| Acronym: |
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Secondary Hyperparathyroidism (SHPT) in Subjects with Chronic Kidney Disease (CKD) on Hemodialysis
|
| Interventions: |
DRUG: MT1013|DRUG: MT1013|DRUG: Etelcalcetide Hydrochloride|DRUG: Placebo
|
| Outcome Measures: |
Primary: Percentage of participants with > 30% reduction from baseline in mean iPTH during the efficacy assessment phase, Weeks 22 to 27, inclusive | Secondary: Percentage of participants with > 50% reduction from baseline in mean iPTH during the efficacy assessment phase, Weeks 22 to 27, inclusive
|
| Sponsor/Collaborators: |
Sponsor: Shaanxi Micot Technology Limited Company
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
112
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
|
| Start Date: |
2024-11-18
|
| Completion Date: |
2026-03
|
| Results First Posted: |
|
| Last Update Posted: |
2025-03-26
|
| Locations: |
First Affiliated Hospital College of Medicine, Zhejiang University, Hangzhou, Zhejiang, 310003, China
|
| URL: |
https://clinicaltrials.gov/show/NCT06690242
|
