Clinical trial Recruiting at 1 site Phase 3 Interventional Ages 18 and up

MT1013 for secondary hyperparathyroidism in people on dialysis

Official title: 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

Run by Shaanxi Micot Pharmaceutical Technology Co., Ltd. · NCT07122401 · Data updated 2026-11-12

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

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment424 (estimated)
SponsorShaanxi Micot Pharmaceutical Technology Co., Ltd.
Industry-sponsored
Drugs / interventionsradiation
Locations1 site (Shanghai, Shanghai Municipality)
StatusRecruiting
StartedSeptember 30, 2025
Main results expectedNovember 26, 2026
Study endsNovember 26, 2026
Registry record updatedNovember 5, 2026
Trial IDNCT07122401 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

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

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.

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 gone: 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.

Who can join: the full rules

Show full inclusion / exclusion 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 it's running

  • Zhongshan Hospital
    Shanghai, Shanghai Municipality, China
    Recruiting

Study contacts

Similar studies

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

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.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.