Secondary Hyperparathyroidism, Chronic Kidney Disease
Conditions
Brief summary
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.
Interventions
DRUGMT1013
MT1013 + dummy cinacalcet
DRUGCinacalcet
Cinacalcet + dummy MT1013
Sponsors
Shaanxi Micot Pharmaceutical Technology Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Participants capable of understanding written information ,willing to participate in, and provide a written informed consent; 2. Male or female, at least 18 years old, 18 kg/m\^2 ≤BMI≤35 kg/m\^2; 3. Receiving regular maintenance dialysis 3 times a week for at least 12 weeks prior to screening； 4. Dialysate calcium concentration≥1.25 mmol/L (2.5 mEq/L); 5. Subjects must have a confirmed diagnosis of Secondary Hyperparathyroidism (SHPT), with a mean pre-dialysis serum intact parathyroid hormone (iPTH) level ≥ 400 pg/mL (42.4 pmol/L), based on measurements from two non-consecutive days before dialysis, within 14 days prior to randomization; 6. Within 14 days prior to randomization, subjects must have serum calcium levels (measured pre-dialysis, or corrected serum calcium if albumin \<40 g/L) ≥ 8.4 mg/dL (2.1 mmol/L) on two non-consecutive pre-dialysis measurements.
Exclusion criteria
1. Underwent parathyroidectomy within 6 months prior to screening, or anticipated parathyroidectomy, ablation or radiation during the study; 2. Gastrointestinal bleeding or peptic ulcer medical history within 6 months prior to screening; 3. New York Heart Association (NYHA) Class III or IV heart failure within 3 months prior to screening; Symptomatic arrhythmia within 6 months prior to screening; History of torsades de pointes (TdP). 4. QTcF interval \>470 ms in males or \>480 ms in females on screening ECG, or other clinically significant ECG abnormalities as determined by the Investigator (e.g., third-degree atrioventricular block, sick sinus syndrome, multifocal frequent ventricular premature contractions, ventricular tachycardia, atrial fibrillation, etc.). 5. Subjects with severe uncontrolled hypertension during the screening period are excluded, defined as systolic blood pressure \>180 mmHg and/or diastolic blood pressure \>110 mmHg despite optimal medical therapy prior to enrollment (excluding transient blood pressure abnormalities during dialysis). 6. History of seizure within 1 year prior to screening, or currently receiving treatment for seizure disorders; 7. Received oral cinacalcet or ivocalcet within 14 days prior to screening, or received Etelcalcetide injection treatment within 4 months prior to screening; 8. Any other condition that, in the Investigator's judgment, would make the subject unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of participants with > 50% reduction from baseline in mean intact parathyroid (iPTH) | EAP（Week 22-27） |
| Percentage of participants with > 30% reduction from baseline in mean iPTH | EAP（Week 22-27） |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Bone Mineral Density | Week 27 | — |
| Change from baseline in serum calcium | EAP（Week 22-27） | — |
| Change From Baseline in serum phosphorus | EAP（Week 22-27） | — |
| Safety and Tolerance | Up to Week 30 | Incidence and severity of TEAE/TESAE |
Countries
China
Contacts
Primary ContactXiaoqiang Ding, MD
Outcome results
None listed