Last updated: May 8, 2025
Sponsor: Shaanxi Micot Technology Limited Company
Overall Status: Active - Recruiting
Phase
2
Condition
Hyperparathyroidism
Neoplasm Metastasis
Treatment
MT1013
Clinical Study ID
NCT06976177
MT1013-II-C02
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Subject capable of understanding written information ,willing to participatein, and provide a written informed consent; 2.Male or female subjects must beat least 18 years old when signing the informed consent; 3.The subjects mustundergo maintenance hemodialysis three times a week or five times two weeks forat least three months; 4.Dialysate calcium concentration≥1.25 mmol/L (2.5mEq/L); 5.Diagnosed of Secondary Hyperparathyroidism (SHPT);
Exclusion
Exclusion Criteria:
- 1.Primary hyperparathyroidism; 2.Refusal to discontinue cinacalcet, etelcalcetide,or other calcimimetics during the study; 3.Has used RANKL inhibitors such asdenosumab within 6 months before screening. 4.Diagnosed with gastrointestinalbleeding within 6 months prior to screening; 5.Subjects with severe uncontrolledhypertension, defined as systolic blood pressure>180 mmHg and/or diastolic bloodpressure>110 mmHg, despite optimal drug treatment prior to enrollment; 6.Thesubjects underwent parathyroidectomy within 6 months prior to screening, or plan toundergo parathyroidectomy during the study; 7.Subjects are allergic or intolerant toany component of the investigational drug; 8.History of epileptic seizures orongoing epilepsy related treatment within 1 year prior to screening;
Study Design
Total Participants: 310
Treatment Group(s): 1
Primary Treatment: MT1013
Phase: 2
Study Start date:
June 07, 2024
Estimated Completion Date:
December 12, 2025
Connect with a study center
First Affiliated Hospital College of Medicine, Zhejiang University
Hangzhou, Zhejiang 310003
ChinaActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.