Status:
RECRUITING
Study of MT1013 Injection for the Treatment of Secondary Hyperparathyroidism (SHPT) Patients With Chronic Kidney Disease Undergoing Maintenance Dialysis
Lead Sponsor:
Shaanxi Micot Pharmaceutical Technology Co., Ltd.
Conditions:
Secondary Hyperparathyroidism (SHPT) in Subjects With Chronic Kidney Disease (CKD) on Hemodialysis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ef...
Eligibility Criteria
Inclusion
- 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 maintenance hemodialysis three times a week or five times two weeks for at least three months； 4.Dialysate calcium concentration≥1.25 mmol/L (2.5 mEq/L); 5.Diagnosed of Secondary Hyperparathyroidism (SHPT);
Exclusion
- Primary hyperparathyroidism; 2.Refusal to discontinue cinacalcet, etelcalcetide, or other calcimimetics during the study; 3.Has used RANKL inhibitors such as denosumab within 6 months before screening. 4.Diagnosed with gastrointestinal bleeding within 6 months prior to screening; 5.Subjects with severe uncontrolled hypertension, defined as systolic blood pressure\>180 mmHg and/or diastolic blood pressure\>110 mmHg, despite optimal drug treatment prior to enrollment; 6.The subjects underwent parathyroidectomy within 6 months prior to screening, or plan to undergo parathyroidectomy during the study; 7.Subjects are allergic or intolerant to any component of the investigational drug； 8.History of epileptic seizures or ongoing epilepsy related treatment within 1 year prior to screening;
Key Trial Info
Start Date :
June 7 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 12 2025
Estimated Enrollment :
310 Patients enrolled
Trial Details
Trial ID
NCT06976177
Start Date
June 7 2024
End Date
December 12 2025
Last Update
May 16 2025
Active Locations (1)
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1
First Affiliated Hospital College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310003