A Multicenter, Randomized,Positive Controlled, and Placebo-controlled Phase II Clinical Study Evaluating the Efficacy and Safety of MT1013 Injection in Patients with Chronic Kidney Disease and Secondary Hyperparathyroidism Undergoing Maintenance Hemodialysis
This is a randomized, positive controlled, and placebo-controlled phase II clinical study to evaluate the efficacy and safety of MT1013 injection in the treatment of chronic kidney disease with secondary hyperparathyroidism (SHPT) undergoing maintenance hemodialysis (MHD) subjects.
• 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;