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
MT1013 is a first-in-class dual-target agonist. This study is a multicenter, randomized, double-blind, double-dummy phase III clinical study being conducetd to evaluate the efficacy and safety of MT1013 compared with active control cinacalcet in secondary hyperparathyroidism patients on maintenance dialysis. Subjects will be 1:1 randomized to receive MT1013 or cinacalcet for 26 weeks. Evaluations of iPTH, Ca, P, BMD, and biomarkers will be done across the study period, to compare efficacy and safety of MT1013 to cinacalcet.
• Participants capable of understanding written information ,willing to participate in, and provide a written informed consent;
• Male or female, at least 18 years old, 18 kg/m\^2 ≤BMI≤35 kg/m\^2;
• Receiving regular maintenance dialysis 3 times a week for at least 12 weeks prior to screening；
• Dialysate calcium concentration≥1.25 mmol/L (2.5 mEq/L);
• 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;
• 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.