MT1013 injection for treating secondary hyperparathyroidism in kidney disease patients on dialysis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial is a multi-center, open-label, single-arm phase IIb study designed to evaluate the long-term efficacy and safety of MT1013 in patients with secondary hyperparathyroidism (SHPT) who are undergoing maintenance hemodialysis. The study consists of two parts, with Part A enrolling approximately 110 subjects for a treatment duration of 52 weeks, and Part B enrolling about 190 subjects for 26 weeks. Participants will receive MT1013 injections and will be monitored for outcomes related to SHPT management.

Why it matters

Who can join: the full rules

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 maintenance hemodialysis three times a week or five times two weeks for at least three months； 4.Dialysate calcium concentration≥1.25 mmol/L (2.5 mEq/L); 5.Diagnosed of Secondary Hyperparathyroidism (SHPT);

Exclusion Criteria:

* 1.Primary hyperparathyroidism; 2.Refusal to discontinue cinacalcet, etelcalcetide, or other calcimimetics during the study; 3.Has used RANKL inhibitors such as denosumab within 6 months before screening. 4.Diagnosed with gastrointestinal bleeding within 6 months prior to screening; 5.Subjects with severe uncontrolled hypertension, defined as systolic blood pressure\>180 mmHg and/or diastolic blood pressure\>110 mmHg, despite optimal drug treatment prior to enrollment; 6.The subjects underwent parathyroidectomy within 6 months prior to screening, or plan to undergo parathyroidectomy during the study; 7.Subjects are allergic or intolerant to any component of the investigational drug； 8.History of epileptic seizures or ongoing epilepsy related treatment within 1 year prior to screening;

Where it's running

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

Study contacts

• Study coordinator: Jiang hua Chen, MD
• Email: chenjianghua@zju.edu.cn
• Phone: 0571-87236844

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• MT1013 for secondary hyperparathyroidism in people on dialysis

  This trial will test whether MT1013 works better than the standard drug cinacalcet for adults on maintenance dialysis who have secondary hyperparathyroidism.

  Recruiting Phase 3 Shaanxi Micot Pharmaceutical Technology Co., Ltd. · Shanghai, Shanghai Municipality · NCT07122401

• MT1011 injection safety and single-dose testing in healthy adults

  This study will test whether single doses of MT1011 are safe and how the body processes them in healthy adults aged 18–45.

  Recruiting Phase 1 Shaanxi Micot Pharmaceutical Technology Co., Ltd. · Beijing, Beijing Municipality · NCT07024160

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.