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

Phase 2

Recruiting

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

• Registration Number: NCT06690242
• Lead Sponsor: Shaanxi Micot Technology Limited Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-13
• Study First Submitted QC: 2024-11-13
• Study First Posted: 2024-11-15
• Study Start: 2024-11-18
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-21
• Last Update Posted: 2025-03-26
• Primary Completion: 2025-08
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 112

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MT1013 dose regimen 1	MT1013	MT1013 injection dose regimen 1 administered intravenously (IV) three times per week for 26 weeks.
MT1013 dose regimen 2	MT1013	MT1013 injection dose regimen 2 administered intravenously (IV) three times per week for 26 weeks.
Etelcalcetide	Etelcalcetide Hydrochloride	Etelcalcetide injection administered intravenously (IV) three times per week for 26 weeks.
Placebo	Placebo	Placebo administered intravenously (IV) three times per week for 26 weeks;

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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