MT1013 Injection for the Treatment of Patients With Secondary Hyperparathyroidism (SHPT) Undergoing Maintenance Dialysis

NCT ID: NCT06747247

Last Updated: 2025-08-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-07
• Study Completion Date: 2025-08-30

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.

Conditions

Secondary Hyperparathyroidism (SHPT) in Subjects With Chronic Kidney Disease (CKD) on Hemodialysis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

SAD Study- MT1013

SAD Study: Patients receive a single dose of MT1013 via IV, three times per week after dialysis.

Group Type: EXPERIMENTAL

MT1013

Intervention Type: DRUG

MT1013 is a dual-agonist polypeptide, not only to control iPTH levels in SHPT patients on maintainence dialysis, but also promote bone formation.

SAD Study- Placebo

SAD Study: Patients receive a single dose of placebo via IV, three times per week after dialysis.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Appear similar to MT1013, but has no treatment effect.

MAD Study- MT1013

MAD Study: Patients receive multiple doses of MT1013 three times a week via IV for a total of 2 weeks or 4 weeks (depending on different dose levels).

Group Type: EXPERIMENTAL

MT1013

Intervention Type: DRUG

MT1013 is a dual-agonist polypeptide, not only to control iPTH levels in SHPT patients on maintainence dialysis, but also promote bone formation.

MAD Study- Placebo

MAD Study: Patients receive multiple doses of placebo three times a week via IV for a total of 2 weeks or 4 weeks (depending on different dose levels).

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Appear similar to MT1013, but has no treatment effect.

Single Arm MT1013 Long Term Treatment

All patients will recieve MT1013 three times a week via IV after dialysis, for a total of 52 weeks.

Group Type: EXPERIMENTAL

MT1013

Intervention Type: DRUG

MT1013 is a dual-agonist polypeptide, not only to control iPTH levels in SHPT patients on maintainence dialysis, but also promote bone formation.

Interventions

MT1013

MT1013 is a dual-agonist polypeptide, not only to control iPTH levels in SHPT patients on maintainence dialysis, but also promote bone formation.

Intervention Type: DRUG

Placebo

Appear similar to MT1013, but has no treatment effect.

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shaanxi Micot Pharmaceutical Technology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

First Affiliated Hospital College of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jiang hua Chen, MD

Role: CONTACT

chenjianghua@zju.edu.cn

+86 - 13905814058

Facility Contacts

Jiang hua Chen, MD

Role: primary

chenjianghua@zju.edu.cn

0571-87236844

Other Identifiers

MT1013-II-C01

Identifier Type: -

Identifier Source: org_study_id