RecruitingPhase 2NCT06976177

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

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


Sponsor

Shaanxi Micot Pharmaceutical Technology Co., Ltd.

Enrollment

310 participants

Start Date

Jun 7, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new injectable drug called MT1013 to see if it can lower dangerously high levels of parathyroid hormone (PTH) in people on dialysis who have a condition called secondary hyperparathyroidism — where overactive parathyroid glands weaken bones and damage other organs. **You may be eligible if...** - You are 18 or older - You have been diagnosed with secondary hyperparathyroidism related to kidney failure - You have been on regular hemodialysis (3 times per week or 5 times every 2 weeks) for at least 3 months - Your dialysate (dialysis fluid) contains an adequate calcium concentration **You may NOT be eligible if...** - You have primary hyperparathyroidism (a different type affecting the glands directly) - You are taking cinacalcet, etelcalcetide, or similar drugs and are unwilling to stop during the study - You have used bone-protecting drugs like denosumab in the past 6 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMT1013

MT1013 is a novel calcimimetic agent


Locations(1)

First Affiliated Hospital College of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

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NCT06976177