Study of MT1013 for the Treatment of Patients With Secondary Hyperparathyroidism

Korábbi kezelés

• Underwent parathyroidectomy within 6 months prior to screening, or anticipated parathyroidectomy, ablation or radiation during the study;
• Gastrointestinal bleeding or peptic ulcer medical history within 6 months prior to screening;
• 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).
• 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).
• History of seizure within 1 year prior to screening, or currently receiving treatment for seizure disorders;
• Received oral cinacalcet or ivocalcet within 14 days prior to screening, or received Etelcalcetide injection treatment within 4 months prior to screening;

Más betegség

• 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.).
• Any other condition that, in the Investigator's judgment, would make the subject unsuitable for participation in this study.

• 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.