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

NCT06690242 | Completed Phase 2

• 1 other identifier: MT1013-II-C03
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Percentage of participants with > 30% reduction from baseline in mean iPTH during the efficacy assessment phase

  Weeks 22 to 27, inclusive

Secondary Outcomes (1)

• Percentage of participants with > 50% reduction from baseline in mean iPTH during the efficacy assessment phase

  Weeks 22 to 27, inclusive

Study Arms (4)

MT1013 dose regimen 1

EXPERIMENTAL

MT1013 injection dose regimen 1 administered intravenously (IV) three times per week for 26 weeks.

Drug: MT1013

MT1013 dose regimen 2

EXPERIMENTAL

MT1013 injection dose regimen 2 administered intravenously (IV) three times per week for 26 weeks.

Drug: MT1013

Etelcalcetide

ACTIVE COMPARATOR

Etelcalcetide injection administered intravenously (IV) three times per week for 26 weeks.

Drug: Etelcalcetide Hydrochloride

Placebo

PLACEBO COMPARATOR

Placebo administered intravenously (IV) three times per week for 26 weeks;

Drug: Placebo

Interventions

MT1013 DRUG

MT1013 is a novel calcimimetic agent

MT1013 dose regimen 1

Etelcalcetide Hydrochloride DRUG

the already-marketed therapeutic agents

Etelcalcetide

Placebo DRUG

The measure does not contain the active ingredients

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Subject capable of understanding written information ,willing to participate in, and provide a written informed consent;
• Male or female subjects must be at least 18 years old when signing the informed consent;
• The subjects must undergo regular maintenance hemodialysis three times a week for at least three months；
• Dialysate calcium concentration≥1.25 mmol/L (2.5 mEq/L);
• Diagnosed of Secondary Hyperparathyroidism (SHPT), with averaged iPTH ≥400 pg/ml14 days prior to screening;
• 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;
• 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;

You may not qualify if:

• The subjects underwent parathyroidectomy within 6 months prior to screening, or plan to undergo parathyroidectomy or ablation or radiation during the study;
• Gastrointestinal bleeding or peptic ulcer medical history within 6 months prior to screening;
• The body mass index of the subjects was less than 18kg/m2 or greater than 35 kg/m2;
• 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;
• History of epileptic seizures or ongoing epilepsy related treatment within 1 year prior to screening;
• Subjects with a history of malignant tumors within the past 5 years prior to screening;
• Subjects are allergic or intolerant to any component of the investigational drug or Etelcalcetide

Sponsors & Collaborators

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

Study Sites (1)

First Affiliated Hospital College of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310003, China

Location

MeSH Terms

Conditions

Hyperparathyroidism, Secondary

Interventions

etelcalcetide hydrochloride

Condition Hierarchy (Ancestors)

Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: November 15, 2024
• Study Start: November 4, 2024
• Primary Completion: October 15, 2025
• Study Completion: October 15, 2025
• Last Updated: February 5, 2026

Record last verified: 2025-03

Locations

CN (1)