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

Last updated: May 8, 2025
Sponsor: Shaanxi Micot Technology Limited Company
Overall Status: Active - Recruiting

Phase

2

Condition

Hyperparathyroidism

Neoplasm Metastasis

Treatment

MT1013

Clinical Study ID

NCT06976177
MT1013-II-C02
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Subject capable of understanding written information ,willing to participatein, and provide a written informed consent; 2.Male or female subjects must beat least 18 years old when signing the informed consent; 3.The subjects mustundergo maintenance hemodialysis three times a week or five times two weeks forat least three months; 4.Dialysate calcium concentration≥1.25 mmol/L (2.5mEq/L); 5.Diagnosed of Secondary Hyperparathyroidism (SHPT);

Exclusion

Exclusion Criteria:

  • 1.Primary hyperparathyroidism; 2.Refusal to discontinue cinacalcet, etelcalcetide,or other calcimimetics during the study; 3.Has used RANKL inhibitors such asdenosumab within 6 months before screening. 4.Diagnosed with gastrointestinalbleeding within 6 months prior to screening; 5.Subjects with severe uncontrolledhypertension, defined as systolic blood pressure>180 mmHg and/or diastolic bloodpressure>110 mmHg, despite optimal drug treatment prior to enrollment; 6.Thesubjects underwent parathyroidectomy within 6 months prior to screening, or plan toundergo parathyroidectomy during the study; 7.Subjects are allergic or intolerant toany component of the investigational drug; 8.History of epileptic seizures orongoing epilepsy related treatment within 1 year prior to screening;

Study Design

Total Participants: 310
Treatment Group(s): 1
Primary Treatment: MT1013
Phase: 2
Study Start date:
June 07, 2024
Estimated Completion Date:
December 12, 2025

Connect with a study center

  • First Affiliated Hospital College of Medicine, Zhejiang University

    Hangzhou, Zhejiang 310003
    China

    Active - Recruiting

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