MT1013 injection for treating secondary hyperparathyroidism in chronic kidney disease patients on hemodialysis

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 study is testing if an injection called MT1013 can help people with chronic kidney disease on hemodialysis who have high levels of parathyroid hormone feel better compared to a placebo and another treatment.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 112 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shaanxi Micot Technology Limited Company (industry)
• Drugs / interventions: radiation
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT06690242 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of MT1013 injection in patients with secondary hyperparathyroidism (SHPT) who are undergoing maintenance hemodialysis. It is a randomized, positive controlled, and placebo-controlled phase II study designed to compare the effects of MT1013 against a placebo and Etelcalcetide Hydrochloride. Participants will be monitored for improvements in their condition and any potential side effects associated with the treatment. The study aims to provide insights into a new therapeutic option for managing SHPT in this patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who are on regular maintenance hemodialysis and have been diagnosed with secondary hyperparathyroidism.

Not a fit: Patients who have undergone parathyroidectomy within the last six months or are planning to have such a procedure may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the management of secondary hyperparathyroidism in patients with chronic kidney disease.

How similar studies have performed: Other studies have explored treatments for secondary hyperparathyroidism, but the specific approach of using MT1013 is novel and has not been extensively tested.

Eligibility criteria

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

Where this trial is running

Hangzhou, Zhejiang

• First Affiliated Hospital College of Medicine, Zhejiang University — Hangzhou, Zhejiang, China (RECRUITING)

Study contacts

• Study coordinator: Jiang hua Chen, MD

Conditions: Secondary Hyperparathyroidism in Subjects with Chronic Kidney Disease on Hemodialysis