MT1013 Injection for the Treatment of Secondary Hyperparathyroidism in Patients With Chronic Kidney Disease

Korábbi kezelés

• 1.The subjects underwent parathyroidectomy within 6 months prior to screening, or plan to undergo parathyroidectomy or ablation or radiation during the study;
• 2.Gastrointestinal bleeding or peptic ulcer medical history within 6 months prior to screening;
• 4.Subjects with severe uncontrolled hypertension, defined as systolic blood pressure>180 mmHg and/or diastolic blood pressure>110 mmHg(Except for transient blood pressure abnormalities seen during dialysis), despite optimal drug treatment prior to enrollment;
• 5.History of epileptic seizures or ongoing epilepsy related treatment within 1 year prior to screening;
• 7.Subjects are allergic or intolerant to any component of the investigational drug or Etelcalcetide

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• 6.Subjects with a history of malignant tumors within the past 5 years prior to screening;

Egyéb

• 3.The body mass index of the subjects was less than 18kg/m2 or greater than 35 kg/m2;

• 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 regular maintenance hemodialysis three times a week for at least three months；
• 4.Dialysate calcium concentration≥1.25 mmol/L (2.5 mEq/L);
• 5.Diagnosed of Secondary Hyperparathyroidism (SHPT), with averaged iPTH ≥400 pg/ml14 days prior to screening;
• 6.Receiving active vitamin D sterols must have had no more than a maximum dose change of 50% within the 1 month prior to screening, remain stable;
• 7.Subject receiving calcium supplements, or phosphate binders must have had no more than a maximum dose change of 50% within the 2 weeks prior to screening, remain stable;