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

Inclusion Criteria:

1. Subject capable of understanding written information ,willing to participatein, and provide a written informed consent;

• 2.Male or female subjects must be at least 18 years old when signing the informedconsent;

• 3.The subjects must undergo regular maintenance hemodialysis three times a week forat 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/ml14days prior to screening;

• 6.Receiving active vitamin D sterols must have had no more than a maximum dosechange of 50% within the 1 month prior to screening, remain stable;

• 7.Subject receiving calcium supplements, or phosphate binders must have had no morethan a maximum dose change of 50% within the 2 weeks prior to screening, remainstable;

Exclusion Criteria:

• 1.The subjects underwent parathyroidectomy within 6 months prior to screening, orplan to undergo parathyroidectomy or ablation or radiation during the study;

• 2.Gastrointestinal bleeding or peptic ulcer medical history within 6 months prior toscreening;

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

• 4.Subjects with severe uncontrolled hypertension, defined as systolic bloodpressure>180 mmHg and/or diastolic blood pressure>110 mmHg(Except for transientblood pressure abnormalities seen during dialysis), despite optimal drug treatmentprior to enrollment;

• 5.History of epileptic seizures or ongoing epilepsy related treatment within 1 yearprior to screening;

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

• 7.Subjects are allergic or intolerant to any component of the investigational drugor Etelcalcetide