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RECRUITING
NCT06976177
PHASE2

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.

View on ClinicalTrials.gov

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

Interventions

DRUG

MT1013

MT1013 is a novel calcimimetic agent

Locations (1)

First Affiliated Hospital College of Medicine, Zhejiang University

Hangzhou, Zhejiang, China