MT1013 Injection for the Treatment of Secondary Hyperparathyroidism in Patients With Chronic Kidney Disease
NCT06690242 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 115
Last updated 2026-02-05
Summary
This is a randomized, positive controlled, and placebo-controlled phase II clinical study to evaluate the efficacy and safety of MT1013 injection in the treatment of chronic kidney disease with secondary hyperparathyroidism (SHPT) undergoing maintenance hemodialysis (MHD) subjects.
Conditions
- Secondary Hyperparathyroidism (SHPT) in Subjects With Chronic Kidney Disease (CKD) on Hemodialysis
Interventions
- DRUG
-
MT1013
MT1013 is a novel calcimimetic agent
- DRUG
-
MT1013
MT1013 is a novel calcimimetic agent
- DRUG
-
Etelcalcetide Hydrochloride
the already-marketed therapeutic agents
- DRUG
-
The measure does not contain the active ingredients
Sponsors & Collaborators
-
Shaanxi Micot Pharmaceutical Technology Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-11-04
- Primary Completion
- 2025-10-15
- Completion
- 2025-10-15
Countries
- China
Study Locations
More Related Trials
-
Investigating the Safety and Efficacy of SHR6508 Injection in the Treatment of Secondary Hyperparathyroidism in Hemodialysis Patients : A Multicenter, Long-term Clinical Trial
NCT06236295 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease on Hemodialysis
NCT01785849 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis
NCT01788046 ·Status: COMPLETED ·Phase: PHASE3
-
Study for Secondary Hyperparathyroidism in Chronic Renal Insufficiency Patients
NCT00042432 ·Status: COMPLETED ·Phase: PHASE2
-
Head-to-Head Study of Etelcalcetide (AMG 416) and Cinacalcet
NCT01896232 ·Status: COMPLETED ·Phase: PHASE3
-
The Trial of SHR6508 in Secondary Hyperparathyroidism
NCT06434961 ·Status: COMPLETED ·Phase: PHASE3
-
Head-to-Head Study of Etelcalcetide and Cinacalcet in Asian Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT)
NCT03299244 ·Status: COMPLETED ·Phase: PHASE3
-
Long-term Safety Study of Paricalcitol Injection in Chronic Kidney Disease Patients With Hemodialysis (HD)
NCT00701805 ·Status: COMPLETED ·Phase: PHASE2
-
A Phase 3 Study of Etelcalcetide in Children With Secondary Hyperparathyroidism Receiving Hemodialysis
NCT03969329 ·Status: RECRUITING ·Phase: PHASE3
-
Etelcalcetide to Treat Secondary Hyperparathyroidism in Hemodialysis Patients With Chronic Kidney Disease-Mineral and Bone Disorder
NCT01414114 ·Status: COMPLETED ·Phase: PHASE2
-
Paricalcitol Compared to Maxacalcitol in Chronic Kidney Disease Patients With Secondary Hyperparathyroidism
NCT00990704 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of an Investigational Medication for the Treatment of Secondary Hyperparathyroidism in Patients on Dialysis
NCT00042653 ·Status: COMPLETED ·Phase: PHASE3
-
The Efficacy and Safety of Microwave Ablation for Mild-to-moderate Secondary Hyperparathyroidism Patients Undergoing Hemodialysis
NCT02332135 ·Status: UNKNOWN ·Phase: NA
-
Paricalcitol Injection Phase II Trial
NCT00646932 ·Status: COMPLETED ·Phase: PHASE2
-
The Effect of Etelcalcetide on CKD-MBD
NCT03960437 ·Status: COMPLETED ·Phase: PHASE2
-
Extension Study of Etelcalcetide in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis
NCT01785875 ·Status: COMPLETED ·Phase: PHASE3
-
Compare the Efficacy of Cinacalcet vs Traditional Vitamin D for Secondary Hyperparathyroidism (SHPT) Among Subjects Undergoing Hemodialysis
NCT01181531 ·Status: COMPLETED ·Phase: PHASE4
-
Comparison of I.V. CTAP201 and Doxercalciferol (Hectorol) in Subjects With Chronic Kidney Disease (CKD) and Secondary Hyperparathyroidism (SHPT)
NCT00792857 ·Status: COMPLETED ·Phase: PHASE1
-
Comparison of Efficacy and Safety of Paricalcitol Injection With Maxacalcitol Injection in Adult Japanese Chronic Kidney Disease Subjects Receiving Hemodialysis With Secondary Hyperparathyroidism
NCT01341782 ·Status: COMPLETED ·Phase: PHASE3
-
A Phase 1 Study to Evaluate PK, Safety and Tolerability of AMG 416
NCT03283098 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of an Investigational Medication for the Treatment of Secondary Hyperparathyroidism in Dialysis Patients
NCT00037635 ·Status: COMPLETED ·Phase: PHASE3
-
Pharmacokinetics and Excretion of [¹⁴C]Etelcalcetide (AMG 416) in Patients With End Stage Renal Disease (ESRD) Receiving Dialysis
NCT02054572 ·Status: COMPLETED ·Phase: PHASE1
-
A Single-dose Study in Paediatric Patients Aged 2 to Less Than 18 Years With Secondary Hyperparathyroidism (sHPT) Receiving Haemodialysis
NCT02833857 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Assess the Efficacy and Safety of Paricalcitol in the Treatment of Chronic Kidney Disease With Secondary Hyperparathyroidism
NCT04994080 ·Status: UNKNOWN ·Phase: PHASE3
-
Dose-response Study of Paricalcitol Injection in Chronic Kidney Disease Patients Receiving Hemodialysis
NCT00667576 ·Status: COMPLETED ·Phase: PHASE2