MT1013 for secondary hyperparathyroidism in people on dialysis

A Multicenter, Randomized, Double-blind, Double-dummy, Phase III Study to Evaluate the Efficacy and Safety of MT1013 Versus Cinacalcet as Active Control in Secondary Hyperparathyroidism Patients on Maintenance Dialysis

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

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 424 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shaanxi Micot Pharmaceutical Technology Co., Ltd. (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07122401 on ClinicalTrials.gov

What this trial studies

MT1013 is a first-in-class dual-target agonist being compared head-to-head with cinacalcet in a randomized, double-blind, double-dummy Phase 3 trial. Adults on maintenance hemodialysis with confirmed secondary hyperparathyroidism (mean pre-dialysis iPTH ≥ 400 pg/mL) are randomized 1:1 to receive MT1013 or cinacalcet for 26 weeks. The study tracks intact PTH, serum calcium, phosphorus, bone mineral density, and other biomarkers throughout treatment. Primary outcomes focus on biochemical control of PTH and mineral metabolism as well as safety and adverse events.

Who should consider this trial

Good fit: Adults (≥18 years) on regular thrice-weekly maintenance dialysis for at least 12 weeks with confirmed secondary hyperparathyroidism (mean pre-dialysis iPTH ≥ 400 pg/mL) and acceptable pre-dialysis calcium levels are the intended participants.

Not a fit: People who are not on maintenance dialysis, who have iPTH below the entry threshold, who recently had parathyroidectomy, or who have contraindications to the study drugs are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, MT1013 could provide better control of PTH and mineral balance than cinacalcet and offer a new treatment option for dialysis patients with SHPT.

How similar studies have performed: Calcimimetics such as cinacalcet have demonstrated benefit in SHPT, but MT1013 is a novel dual-target agent and its advantages over existing therapies remain to be shown.

Eligibility criteria

Inclusion Criteria:

1. Participants capable of understanding written information ,willing to participate in, and provide a written informed consent;
2. Male or female, at least 18 years old, 18 kg/m\^2 ≤BMI≤35 kg/m\^2;
3. Receiving regular maintenance dialysis 3 times a week for at least 12 weeks prior to screening；
4. Dialysate calcium concentration≥1.25 mmol/L (2.5 mEq/L);
5. Subjects must have a confirmed diagnosis of Secondary Hyperparathyroidism (SHPT), with a mean pre-dialysis serum intact parathyroid hormone (iPTH) level ≥ 400 pg/mL (42.4 pmol/L), based on measurements from two non-consecutive days before dialysis, within 14 days prior to randomization;
6. Within 14 days prior to randomization, subjects must have serum calcium levels (measured pre-dialysis, or corrected serum calcium if albumin \<40 g/L) ≥ 8.4 mg/dL (2.1 mmol/L) on two non-consecutive pre-dialysis measurements.

Exclusion Criteria:

1. Underwent parathyroidectomy within 6 months prior to screening, or anticipated parathyroidectomy, ablation or radiation during the study;
2. Gastrointestinal bleeding or peptic ulcer medical history within 6 months prior to screening;
3. New York Heart Association (NYHA) Class III or IV heart failure within 3 months prior to screening; Symptomatic arrhythmia within 6 months prior to screening; History of torsades de pointes (TdP).
4. QTcF interval \>470 ms in males or \>480 ms in females on screening ECG, or other clinically significant ECG abnormalities as determined by the Investigator (e.g., third-degree atrioventricular block, sick sinus syndrome, multifocal frequent ventricular premature contractions, ventricular tachycardia, atrial fibrillation, etc.).
5. Subjects with severe uncontrolled hypertension during the screening period are excluded, defined as systolic blood pressure \>180 mmHg and/or diastolic blood pressure \>110 mmHg despite optimal medical therapy prior to enrollment (excluding transient blood pressure abnormalities during dialysis).
6. History of seizure within 1 year prior to screening, or currently receiving treatment for seizure disorders;
7. Received oral cinacalcet or ivocalcet within 14 days prior to screening, or received Etelcalcetide injection treatment within 4 months prior to screening;
8. Any other condition that, in the Investigator's judgment, would make the subject unsuitable for participation in this study.

Where this trial is running

Shanghai, Shanghai Municipality

• Zhongshan Hospital — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Xiaoqiang Ding, MD

Conditions Secondary Hyperparathyroidism, Chronic Kidney Disease