MT1013 is a first-in-class dual-target agonist. This study is a multicenter, randomized, double-blind, double-dummy phase III clinical study being conducetd to evaluate the efficacy and safety of MT1013 compared with active control cinacalcet in secondary hyperparathyroidism patients on maintenance dialysis. Subjects will be 1:1 randomized to receive MT1013 or cinacalcet for 26 weeks. Evaluations of iPTH, Ca, P, BMD, and biomarkers will be done across the study period, to compare efficacy and safety of MT1013 to cinacalcet.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
424
MT1013 + dummy cinacalcet
Cinacalcet + dummy MT1013
Zhongshan Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGPercentage of participants with > 50% reduction from baseline in mean intact parathyroid (iPTH)
Time frame: EAP(Week 22-27)
Percentage of participants with > 30% reduction from baseline in mean iPTH
Time frame: EAP(Week 22-27)
Change From Baseline in Bone Mineral Density
Time frame: Week 27
Change from baseline in serum calcium
Time frame: EAP(Week 22-27)
Change From Baseline in serum phosphorus
Time frame: EAP(Week 22-27)
Safety and Tolerance
Incidence and severity of TEAE/TESAE
Time frame: Up to Week 30
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.