Trials / Recruiting
RecruitingNCT06976177
Study of MT1013 Injection for the Treatment of Secondary Hyperparathyroidism (SHPT) Patients With Chronic Kidney Disease Undergoing Maintenance Dialysis
A Multi-center, Open, Single-arm Phase IIb Clinical Study to Evaluate the Safety and Efficacy of MT1013 Injection for the Treatment of Secondary Hyperparathyroidism (SHPT) Patients With Chronic Kidney Disease Undergoing Maintenance Dialysis
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 310 (estimated)
- Sponsor
- Shaanxi Micot Pharmaceutical Technology Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a multi-center, open, single-arm phase IIb clinical study comprising 2 parts, which Part A will enroll about 110 subjects, and Part B will enroll about 190 subjects to investigate long-term efficacy and safety of MT1013 after treatment.The treatment duration for Part A MAD study is 52 weeks and the duration for Part B study is 26 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | MT1013 | MT1013 is a novel calcimimetic agent |
Timeline
- Start date
- 2024-06-07
- Primary completion
- 2025-08-19
- Completion
- 2025-12-12
- First posted
- 2025-05-16
- Last updated
- 2025-05-16
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06976177. Inclusion in this directory is not an endorsement.