Overview

This is a phase II study comprising 3 parts, which Part A/Part B a double-blind, randomized, placebo-controlled SAD/MAD study, and Part C a single arm study to investigate long-term efficacy and safety of MT1013 after 52 week treatment.The treatment duration for Part B MAD study is 2-4 weeks and the duration for Part C study is 52 weeks.

Eligibility

1. Receiving hemodialysis 3 times weekly for at least 3 months, and have adequate hemodialysis with a delivered Kt/V≥1.2 or urea reduction ratio (URR)≥65% within 4 weeks prior to screening;
2. Dialysis prescription dialysate calcium concentration must be ≥2.25 mEq/L, and

   stable for at least 4 weeks prior to screening, remain stable for the duration of the study;

3. Diagnosed of Secondary Hyperparathyroidism (SHPT), with averaged iPTH ≥300 pg/ml

   (42.4pmol/L) 14 days prior to screening;

4. 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;

5. 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.