NCT06747247

A Clinical Study Evaluating the Safety, Tolerability, and Efficacy of MT1013 in Hemodialysis Subjects With Secondary Hyperparathyroidism

A Double-blind, Randomized, Placebo-controlled, Single-dose Escalation and Multi-dose Escalation Clinical Study Evaluating the Safety, Tolerability, and Efficacy of MT1013 in Hemodialysis Subjects With Secondary Hyperparathyroidism, Along With a Single-arm Study Assessing the Long-term Efficacy and Safety of MT1013

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Shaanxi Micot Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

A multicenter, Phase II, randomized, double-blind, single ascending dose (SAD) and multiple ascending dose (MAD), as well as single-arm clinical study evaluating the long-term efficacy and safety of MT1013 in hemodialysis subjects with secondary hyperparathyroidism. The SAD study consists of five cohorts at doses of 5, 10, 20, 40, and 60 mg. The MAD study consists of three cohorts at doses of 5, 10, and 20 mg. In both the SAD and MAD studies, each cohort includes 8 subjects (6 subjects receive the active investigational drug, and 2 subjects receive matching placebo), and the cohorts are conducted sequentially. In the long-term dosing cohort, all subjects will undergo regular hemodialysis three times per week, receiving the drug once after each hemodialysis session for a total duration of 52 weeks

Conditions

• Secondary Hyperparathyroidism (SHPT) in Subjects With Chronic Kidney Disease (CKD) on Hemodialysis

Interventions

Type	Name	Description
DRUG	Long-term Dosing Cohort	All subjects will undergo regular hemodialysis three times per week. Administration of MT1013occurs once after each hemodialysis session and will continue for 52 weeks. The first 10 weeks constitute the dose-titration period, during which the drug dose is titrated every 3 weeks based on iPTH and serum corrected calcium levels. During the maintenance dosing period, doses is adjusted based on iPTH and serum corrected calcium levels.
DRUG	Single ascending doses of MT1013	All subjects will receive a single dose (MT1013 or placebo) only after a single hemodialysis session
DRUG	Multiple ascending doses of MT1013	All subjects will undergo hemodialysis three times per week. Dosing (MT1013 or placebo) will occur once after each hemodialysis session, continuing for either 2 or 4 weeks (treatment period).

Timeline

• Start date: 2023-04-07
• Primary completion: 2025-05-12
• Completion: 2025-05-12
• First posted: 2024-12-24
• Last updated: 2026-02-06

Locations

1 site across 1 country: China