NCT06976177RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 16 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 310 (estimated)
- First submitted
- 8 May 2025
- Start date
- 7 Jun 2024
- Primary completion date
- 19 Aug 2025
- Lead sponsor
- Shaanxi Micot Pharmaceutical Technology Co., Ltd.
- Diseases
- Chronic kidney disease
- NCT number
- NCT06976177
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 310
- From 7 Jun 2024 to the primary completion date, 19 Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 1.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;
Who the study is looking for
- 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);
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| First Affiliated Hospital College of Medicine, Zhejiang University Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.