A Multicenter, Randomized,Positive Controlled, and Placebo-controlled Phase II Clinical Study Evaluating the Efficacy and Safety of MT1013 Injection in Patients with Chronic Kidney Disease and Secondary Hyperparathyroidism Undergoing Maintenance Hemodialysis

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 1\. Subject capable of understanding written information ,willing to participate in, and provide a written informed consent;

• 2.Male or female subjects must be at least 18 years old when signing the informed consent;

• 3.The subjects must undergo regular maintenance hemodialysis three times a week for at least three months;

• 4.Dialysate calcium concentration≥1.25 mmol/L (2.5 mEq/L);

• 5.Diagnosed of Secondary Hyperparathyroidism (SHPT), with averaged iPTH ≥400 pg/ml14 days prior to screening;

• 6.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;

• 7.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;

Locations
Other Locations
China
First Affiliated Hospital College of Medicine, Zhejiang University
RECRUITING
Hangzhou
Contact Information
Primary
Jiang hua Chen, MD
chenjianghua@zju.edu.cn
0571-87236844
Time Frame
Start Date: 2024-11-18
Estimated Completion Date: 2026-03
Participants
Target number of participants: 112
Treatments
Experimental: MT1013 dose regimen 1
MT1013 injection dose regimen 1 administered intravenously (IV) three times per week for 26 weeks.
Experimental: MT1013 dose regimen 2
MT1013 injection dose regimen 2 administered intravenously (IV) three times per week for 26 weeks.
Active_comparator: Etelcalcetide
Etelcalcetide injection administered intravenously (IV) three times per week for 26 weeks.
Placebo_comparator: Placebo
Placebo administered intravenously (IV) three times per week for 26 weeks;
Related Therapeutic Areas
Sponsors
Leads: Shaanxi Micot Pharmaceutical Technology Co., Ltd.

This content was sourced from clinicaltrials.gov

Similar Clinical Trials