Clinical trial NCT06747247: MT1013 Injection for the Treatment of Patients With Secondary Hyperparathyroidism (SHPT) Undergoing Maintenance Dialysis
Official title: A Double-blind, Randomized, Placebo-controlled Clinical Trials With Single-ascending Dose(SAD) and Multiple-ascending Dose(MAD) Arms, as Well as a Single-arm to Assess the Safety, Tolerability, and Efficacy of MT1013 Injection in Patients With Secondary Hyperparathyroidism (SHPT) Undergoing Maintenance Dialysis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Secondary Hyperparathyroidism (SHPT) in Subjects With Chronic Kidney Disease (CKD) on Hemodialysis
Lead sponsor: Shaanxi Micot Pharmaceutical Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-12-24
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Part A (SAD Study): 5 dose levels are selected for SAD study, placebo-controlled Part B (MAD Study): 3 dose levels are selected for MAD study, placebo-controlled, treatment duration is 2w, 4w and 4w respectively.

Part C (Single-arm Study): 1 dose level (with strating dose and titration period) is selected for the single arm study, the treatment duration is 52w.
Primary purpose: TREATMENT

Brief summary: 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 criteria: 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.

Primary outcomes:
measure: SAD/MAD Studies: treatment-emergent adverse events (TEAEs)
timeFrame: SAD：8 days. MAD：2- 4weeks (+7 days)
measure: Single Arm MT1013 Long Term Treatment Study: Proportion of subjects with > 30% reduction in iPTH compared to baseline level.
timeFrame: 14 weeks
Secondary outcomes:
measure: Proportion of subjects with > 30% reduction in iPTH compared to baseline level at evaluated timepoints.
timeFrame: SAD: 8 days. MAD: 2-4 weeks (+7 days). Single Arm: 52 weeks
measure: Change from baseline in mean serum iPTH levels at evaluated timepoints.
timeFrame: SAD: 8 days. MAD: 2-4 weeks (+7 days). Single Arm: 52 weeks
measure: Change from baseline in corrected Ca levels at evaluated timepoints.
timeFrame: SAD: 8 days. MAD: 2-4 weeks (+7 days). Single Arm: 52 weeks
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: First Affiliated Hospital College of Medicine, Zhejiang University
state: Zhejiang
Study officials:
References: