drugset / Trial / NCT06976177

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

NCT06976177

Phase 2 Recruiting 310 enrolled Shaanxi Micot Pharmaceutical Technology Co., Ltd.
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2024-06-07
Primary completion
2025-08-19
Completion
2025-12-12

Drugs

EvaluationDrugModalityDoseRoute
Subject MT1013 Peptide Intravenous