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Study of MT1013 Injection for the Treatment of Secondary Hyperparathyroidism (SHPT) Patients With Chronic Kidney Disease Undergoing Maintenance Dialysis
Sponsor: Shaanxi Micot Pharmaceutical Technology Co., Ltd.
Summary
This is a multi-center, open, single-arm phase IIb clinical study comprising 2 parts, which Part A will enroll about 110 subjects, and Part B will enroll about 190 subjects to investigate long-term efficacy and safety of MT1013 after treatment.The treatment duration for Part A MAD study is 52 weeks and the duration for Part B study is 26 weeks.
Official title: A Multi-center, Open, Single-arm Phase IIb Clinical Study to Evaluate the Safety and Efficacy of MT1013 Injection for the Treatment of Secondary Hyperparathyroidism (SHPT) Patients With Chronic Kidney Disease Undergoing Maintenance Dialysis
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
310
Start Date
2024-06-07
Completion Date
2025-12-12
Last Updated
2025-05-16
Healthy Volunteers
No
Conditions
Interventions
MT1013
MT1013 is a novel calcimimetic agent
Locations (1)
First Affiliated Hospital College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China