Tests MT1013 injection for high parathyroid hormone in adults on dialysis
Tests MT1013 injection in adults with kidney disease on dialysis who have high parathyroid hormone.
Plain-language title generated from the registry record
Registry title: Study of MT1013 Injection for the Treatment of Secondary Hyperparathyroidism (SHPT) Patients With Chronic Kidney Disease Undergoing Maintenance Dialysis
Key facts
- Where
- Hangzhou, ChinaSee the site
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with secondary hyperparathyroidism who are on long-term hemodialysis because of chronic kidney disease.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Secondary hyperparathyroidism (SHPT) in people on maintenance hemodialysis three times a week or five times in two weeks for at least three months. Dialysate calcium of 1.25 mmol/L (2.5 mEq/L) or more.
- Earlier treatment
- People must be willing to stop cinacalcet, etelcalcetide or other calcimimetics during the study. They cannot have used RANKL inhibitors such as denosumab in the 6 months before screening.
Main reasons for not taking part
- Primary hyperparathyroidism
- Parathyroid gland surgery in the last 6 months, or planned during the study
- Stomach or bowel bleeding in the last 6 months
- Severe uncontrolled high blood pressure (above 180 mmHg systolic and/or 110 mmHg diastolic) despite treatment
- Seizures or epilepsy treatment in the last year
This trial only enrols participants on dialysis. The registry sentence this rests on: 3.The subjects must undergo maintenance hemodialysis three times a week or five times two weeks for at least three months
Read by machine on 9 November 2026.
Where in China
- First Affiliated Hospital College of Medicine, Zhejiang UniversityHangzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Shaanxi Micot Pharmaceutical Technology Co., Ltd.
- Trial code
- NCT06976177
- Record updated
- 16 May 2025
- Original description
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.Read full original descriptionShow less
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
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.
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: 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.