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

A Multi-center, Open, Single-arm Phase IIb Clinical Study to Evaluate the Safety and Efficacy of MT1013 Injection for the Treatment of Secondary Hyperparathyroidism (SHPT) Patients With Chronic Kidney Disease Undergoing Maintenance Dialysis

This study is testing if MT1013 injections can help people with kidney disease on dialysis manage their secondary hyperparathyroidism better over a year.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 310 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shaanxi Micot Pharmaceutical Technology Co., Ltd. (Industry-sponsored)
• Drugs / interventions: denosumab
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT06976177 on ClinicalTrials.gov

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.

Who should consider this trial

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

Not a fit: Patients with primary hyperparathyroidism or those who have used certain medications like RANKL inhibitors recently 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 on dialysis.

How similar studies have performed: While this approach is being explored in this specific context, similar studies have shown promise in managing secondary hyperparathyroidism, indicating potential for success.

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 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 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