MT1013 Injection for the Treatment of Secondary Hyperparathyroidism in Patients With Chronic Kidney Disease

A Multicenter, Randomized,Positive Controlled, and Placebo-controlled Phase II Clinical Study Evaluating the Efficacy and Safety of MT1013 Injection in Patients With Chronic Kidney Disease and Secondary Hyperparathyroidism Undergoing Maintenance Hemodialysis

This is a randomized, positive controlled, and placebo-controlled phase II clinical study to evaluate the efficacy and safety of MT1013 injection in the treatment of chronic kidney disease with secondary hyperparathyroidism (SHPT) undergoing maintenance hemodialysis (MHD) subjects.

Study Overview

• Status: Completed
• Conditions: Secondary Hyperparathyroidism (SHPT) in Subjects With Chronic Kidney Disease (CKD) on Hemodialysis
• Intervention / Treatment: Drug: MT1013; Drug: Etelcalcetide Hydrochloride; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 115
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • First Affiliated Hospital College of Medicine, Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 1. Subject capable of understanding written information ,willing to participate in, and provide a written informed consent;
• 2.Male or female subjects must be at least 18 years old when signing the informed consent;
• 3.The subjects must undergo regular maintenance hemodialysis three times a week for at least three months；
• 4.Dialysate calcium concentration≥1.25 mmol/L (2.5 mEq/L);
• 5.Diagnosed of Secondary Hyperparathyroidism (SHPT), with averaged iPTH ≥400 pg/ml14 days prior to screening;
• 6.Receiving active vitamin D sterols must have had no more than a maximum dose change of 50% within the 1 month prior to screening, remain stable;
• 7.Subject receiving calcium supplements, or phosphate binders must have had no more than a maximum dose change of 50% within the 2 weeks prior to screening, remain stable;

Exclusion Criteria:

• 1.The subjects underwent parathyroidectomy within 6 months prior to screening, or plan to undergo parathyroidectomy or ablation or radiation during the study;
• 2.Gastrointestinal bleeding or peptic ulcer medical history within 6 months prior to screening;
• 3.The body mass index of the subjects was less than 18kg/m2 or greater than 35 kg/m2;
• 4.Subjects with severe uncontrolled hypertension, defined as systolic blood pressure>180 mmHg and/or diastolic blood pressure>110 mmHg(Except for transient blood pressure abnormalities seen during dialysis), despite optimal drug treatment prior to enrollment;
• 5.History of epileptic seizures or ongoing epilepsy related treatment within 1 year prior to screening;
• 6.Subjects with a history of malignant tumors within the past 5 years prior to screening;
• 7.Subjects are allergic or intolerant to any component of the investigational drug or Etelcalcetide

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MT1013 dose regimen 1; MT1013 injection dose regimen 1 administered intravenously (IV) three times per week for 26 weeks.	Drug: MT1013; MT1013 is a novel calcimimetic agent
Experimental: MT1013 dose regimen 2; MT1013 injection dose regimen 2 administered intravenously (IV) three times per week for 26 weeks.	Drug: MT1013; MT1013 is a novel calcimimetic agent
Active Comparator: Etelcalcetide; Etelcalcetide injection administered intravenously (IV) three times per week for 26 weeks.	Drug: Etelcalcetide Hydrochloride; the already-marketed therapeutic agents
Placebo Comparator: Placebo; Placebo administered intravenously (IV) three times per week for 26 weeks;	Drug: Placebo; The measure does not contain the active ingredients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of participants with > 30% reduction from baseline in mean iPTH during the efficacy assessment phase	Weeks 22 to 27, inclusive

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of participants with > 50% reduction from baseline in mean iPTH during the efficacy assessment phase	Weeks 22 to 27, inclusive

Collaborators and Investigators

• Sponsor: Shaanxi Micot Pharmaceutical Technology Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2024
• Primary Completion (Actual): August 30, 2025
• Study Completion (Actual): August 30, 2025

Study Registration Dates

• First Submitted: November 13, 2024
• First Submitted That Met QC Criteria: November 13, 2024
• First Posted (Actual): November 15, 2024

Study Record Updates

• Last Update Posted (Actual): July 22, 2026
• Last Update Submitted That Met QC Criteria: July 20, 2026
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Parathyroid Diseases; Hyperparathyroidism; Hyperparathyroidism, Secondary; etelcalcetide hydrochloride
• Other Study ID Numbers: MT1013-II-C03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No