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

Phase 2

Recruiting

• Conditions: Secondary Hyperparathyroidism (SHPT) in Subjects With Chronic Kidney Disease (CKD) on Hemodialysis
• Interventions: Drug: MT1013; Drug: Placebo

• Registration Number: NCT06747247
• Lead Sponsor: Shaanxi Micot Technology Limited Company

Brief Summary

This is a phase II study comprising 3 parts, which Part A/Part B a double-blind, randomized, placebo-controlled SAD/MAD study, and Part C a single arm study to investigate long-term efficacy and safety of MT1013 after 52 week treatment.The treatment duration for Part B MAD study is 2-4 weeks and the duration for Part C study is 52 weeks.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-12
• Status Verified: 2024-12
• Study First Submitted: 2024-12-18
• Study First Submitted QC: 2024-12-20
• Last Update Submitted: 2024-12-20
• Study First Posted: 2024-12-24
• Last Update Posted: 2024-12-24
• Primary Completion: 2025-04-30
• Study Completion: 2025-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single Arm MT1013 Long Term Treatment	MT1013	All patients will recieve MT1013 three times a week via IV after dialysis, for a total of 52 weeks.
SAD Study- MT1013	MT1013	SAD Study: Patients receive a single dose of MT1013 via IV, three times per week after dialysis.
SAD Study- Placebo	Placebo	SAD Study: Patients receive a single dose of placebo via IV, three times per week after dialysis.
MAD Study- MT1013	MT1013	MAD Study: Patients receive multiple doses of MT1013 three times a week via IV for a total of 2 weeks or 4 weeks (depending on different dose levels).
MAD Study- Placebo	Placebo	MAD Study: Patients receive multiple doses of placebo three times a week via IV for a total of 2 weeks or 4 weeks (depending on different dose levels).

Primary Outcome Measures

Name	Time	Method
SAD/MAD Studies: treatment-emergent adverse events (TEAEs)	SAD：8 days. MAD：2- 4weeks (+7 days)	SAD arm: All patients receive a single dose of MT1013/Placebo after dialysis. MAD arm：All patients receive MT1013/Placebo three times a week after dialysis for a total of 2 or 4 weeks.
Single Arm MT1013 Long Term Treatment Study: Proportion of subjects with > 30% reduction in iPTH compared to baseline level.	14 weeks

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects with > 30% reduction in iPTH compared to baseline level at evaluated timepoints.	SAD: 8 days. MAD: 2-4 weeks (+7 days). Single Arm: 52 weeks
Change from baseline in mean serum iPTH levels at evaluated timepoints.	SAD: 8 days. MAD: 2-4 weeks (+7 days). Single Arm: 52 weeks
Change from baseline in corrected Ca levels at evaluated timepoints.	SAD: 8 days. MAD: 2-4 weeks (+7 days). Single Arm: 52 weeks

Trial Locations

Locations (1)

First Affiliated Hospital College of Medicine, Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China