Clinical Trial

Study of MT1013 Injection for the Treatment of Secondary Hyperparathyroidism (SHPT) Patients With Chronic Kidney Disease Undergoing Maintenance Dialysis

Recruiting Phase 2
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Record status
This record was last updated May 16, 2025 (before its estimated August 19, 2025 completion). Its status may not reflect the trial's current state.
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.
Trial Details
NCT Number NCT06976177
Lead Sponsor Shaanxi Micot Pharmaceutical Technology Co., Ltd.
Conditions Secondary Hyperparathyroidism (SHPT) in Subjects With Chronic Kidney Disease (CKD) on Hemodialysis
Enrollment 310 participants
Start Date 2024-06-07
Primary Completion 2025-08-19 (estimated)
Study Completion 2025-12-12 (estimated)
Updated on ClinicalTrials.gov 2025-05-16