Secondary Hyperparathyroidism (SHPT) in Subjects With Chronic Kidney Disease (CKD) on HemodialysisPhase 2NCT06976177
Study of MT1013 Injection for the Treatment of Secondary Hyperparathyroidism (SHPT) Patients With Chronic Kidney Disease Undergoing Maintenance Dialysis
A Phase 2 study testing MT1013 in people with Secondary Hyperparathyroidism (SHPT) in Subjects With Chronic Kidney Disease (CKD) on Hemodialysis, run by Shaanxi Micot Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial 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 efficacy and safety of MT1013 after treatment.The treatment duration for Part A MAD study is 52 weeks and the duration… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Secondary Hyperparathyroidism (SHPT) in Subjects With Chronic Kidney Disease (CKD) on Hemodialysis
- What is being tested?
- MT1013
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- 1 siteChina
- Study dates
- 7 Jun 2024to 12 Dec 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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);
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital College of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310003
Jianghua Chen, Master of Medical Science, 8613905814085, chenjianghua@zju.edu.cn
About this study
Official title: 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.
- Conditions
- Secondary Hyperparathyroidism (SHPT) in Subjects With Chronic Kidney Disease (CKD) on Hemodialysis
- Being tested
- MT1013
- Medical subject headings
- Hyperparathyroidism, Secondary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT1013Drug
MT1013 is a novel calcimimetic agent
| Study group | Role | What they receive |
|---|---|---|
| MT1013 | Experimental | MT1013 injection administered intravenously (IV) three times per week for 52(Part A) or 26(Part B) weeks Receives: Drug: MT1013 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurrence of adverse events within 26 weeks
The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).
Measured: Baseline up to 26 weeks
Secondary outcomes (1)
Percentage of participants with iPTH during 150-300pg/mL at week 26
Measured: at week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start7 Jun 2024
- Primary completion19 Aug 2025 (estimated)
- Study completion12 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Secondary Hyperparathyroidism (SHPT) in Subjects With Chronic Kidney Disease (CKD) on HemodialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 310 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaanxi Micot Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06976177
- Sponsor's protocol ID
- MT1013-II-C02
- Status last verified
- Apr 2025
- First submitted
- 8 May 2025
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06976177
- Acronym / sponsor ID
- MT1013-II-C02
- Conditions
- Secondary Hyperparathyroidism (SHPT) in Subjects With Chronic Kidney Disease (CKD) on Hemodialysis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- Shaanxi Micot Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Jun 2024 (actual)
- Primary completion
- 19 Aug 2025 (estimated)
- Study completion
- 12 Dec 2025 (estimated)
- First posted
- 16 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MT1013 | Experimental | Drug: MT1013MT1013 injection administered intravenously (IV) three times per week for 52(Part A) or 26(Part B) weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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);
Key exclusion criteria (1 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MT1013MT1013 is a novel calcimimetic agent | Drug | MT1013 |
Primary outcome
The occurrence of adverse events within 26 weeks
Time frame: Baseline up to 26 weeks
The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).
1 secondary outcome
Percentage of participants with iPTH during 150-300pg/mL at week 26
Time frame: at week 26
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
Related trials for Secondary Hyperparathyroidism (SHPT) in Subjects With Chronic Kidney Disease (CKD) on Hemodialysis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MT1013 in people with Secondary Hyperparathyroidism (SHPT) in Subjects With Chronic Kidney Disease (CKD) on Hemodialysis, run by Shaanxi Micot Pharmaceutical Technology Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiang hua Chen, MD (0571-87236844, chenjianghua@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The occurrence of adverse events within 26 weeks (time frame: Baseline up to 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.