Secondary Hyperparathyroidism (SHPT) in Subjects With Chronic Kidney Disease (CKD) on HemodialysisPhase 2NCT06690242
MT1013 Injection for the Treatment of Secondary Hyperparathyroidism in Patients With Chronic Kidney Disease
A Phase 2 study testing MT1013 and Etelcalcetide Hydrochloride 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 randomized, positive controlled, and placebo-controlled phase II clinical study to evaluate the efficacy and safety of MT1013 injection in the treatment of chronic kidney disease with secondary hyperparathyroidism (SHPT) undergoing maintenance hemodialysis (MHD) subjects. 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 and Etelcalcetide Hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 115 participants
- Where
- 1 siteChina
- Study dates
- 4 Nov 2024to 30 Aug 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 regular maintenance hemodialysis three times a week for at least three months；
- 4.Dialysate calcium concentration≥1.25 mmol/L (2.5 mEq/L);
- 5.Diagnosed of Secondary Hyperparathyroidism (SHPT), with averaged iPTH ≥400 pg/ml14 days prior to screening;
- 6.Receiving active vitamin D sterols must have had no more than a maximum dose change of 50% within the 1 month prior to screening, remain stable;
- 7.Subject receiving calcium supplements, or phosphate binders must have had no more than a maximum dose change of 50% within the 2 weeks prior to screening, remain stable;
Who cannot join
- 1.The subjects underwent parathyroidectomy within 6 months prior to screening, or plan to undergo parathyroidectomy or ablation or radiation during the study;
- 2.Gastrointestinal bleeding or peptic ulcer medical history within 6 months prior to screening;
- 3.The body mass index of the subjects was less than 18kg/m2 or greater than 35 kg/m2;
- 4.Subjects with severe uncontrolled hypertension, defined as systolic blood pressure>180 mmHg and/or diastolic blood pressure>110 mmHg(Except for transient blood pressure abnormalities seen during dialysis), despite optimal drug treatment prior to enrollment;
- 5.History of epileptic seizures or ongoing epilepsy related treatment within 1 year prior to screening;
- 6.Subjects with a history of malignant tumors within the past 5 years prior to screening;
- 7.Subjects are allergic or intolerant to any component of the investigational drug or Etelcalcetide
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital College of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310003
About this study
Official title: A Multicenter, Randomized,Positive Controlled, and Placebo-controlled Phase II Clinical Study Evaluating the Efficacy and Safety of MT1013 Injection in Patients With Chronic Kidney Disease and Secondary Hyperparathyroidism Undergoing Maintenance Hemodialysis
This is a randomized, positive controlled, and placebo-controlled phase II clinical study to evaluate the efficacy and safety of MT1013 injection in the treatment of chronic kidney disease with secondary hyperparathyroidism (SHPT) undergoing maintenance hemodialysis (MHD) subjects.
- Conditions
- Secondary Hyperparathyroidism (SHPT) in Subjects With Chronic Kidney Disease (CKD) on Hemodialysis
- Being tested
- MT1013, Etelcalcetide Hydrochloride, Placebo
- 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
MT1013Drug
MT1013 is a novel calcimimetic agent
Etelcalcetide HydrochlorideDrug
the already-marketed therapeutic agents
PlaceboDrug
The measure does not contain the active ingredients
| Study group | Role | What they receive |
|---|---|---|
| MT1013 dose regimen 1 | Experimental | MT1013 injection dose regimen 1 administered intravenously (IV) three times per week for 26 weeks. Receives: Drug: MT1013 |
| MT1013 dose regimen 2 | Experimental | MT1013 injection dose regimen 2 administered intravenously (IV) three times per week for 26 weeks. Receives: Drug: MT1013 |
| Etelcalcetide | Active comparator | Etelcalcetide injection administered intravenously (IV) three times per week for 26 weeks. Receives: Drug: Etelcalcetide Hydrochloride |
| Placebo | Placebo comparator | Placebo administered intravenously (IV) three times per week for 26 weeks; Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with > 30% reduction from baseline in mean iPTH during the efficacy assessment phase
Measured: Weeks 22 to 27, inclusive
Secondary outcomes (1)
Percentage of participants with > 50% reduction from baseline in mean iPTH during the efficacy assessment phase
Measured: Weeks 22 to 27, inclusive
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2024
- Study start4 Nov 2024
- Primary completion30 Aug 2025
- Study completion30 Aug 2025
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 115 participants (actual)
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
- NCT06690242
- Sponsor's protocol ID
- MT1013-II-C03
- Status last verified
- Mar 2025
- First submitted
- 13 Nov 2024
- Last updated
- 22 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized,Positive Controlled, and Placebo-controlled Phase II Clinical Study Evaluating the Efficacy and Safety of MT1013 Injection in Patients With Chronic Kidney Disease and Secondary Hyperparathyroidism Undergoing Maintenance Hemodialysis
- ClinicalTrials.gov ID
- NCT06690242
- Acronym / sponsor ID
- MT1013-II-C03
- Conditions
- Secondary Hyperparathyroidism (SHPT) in Subjects With Chronic Kidney Disease (CKD) on Hemodialysis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Shaanxi Micot Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Nov 2024 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- 30 Aug 2025 (actual)
- First posted
- 15 Nov 2024 (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 randomized, positive controlled, and placebo-controlled phase II clinical study to evaluate the efficacy and safety of MT1013 injection in the treatment of chronic kidney disease with secondary hyperparathyroidism (SHPT) undergoing maintenance hemodialysis (MHD) subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MT1013 dose regimen 1 | Experimental | Drug: MT1013MT1013 injection dose regimen 1 administered intravenously (IV) three times per week for 26 weeks. |
| MT1013 dose regimen 2 | Experimental | Drug: MT1013MT1013 injection dose regimen 2 administered intravenously (IV) three times per week for 26 weeks. |
| Etelcalcetide | Active comparator | Drug: Etelcalcetide HydrochlorideEtelcalcetide injection administered intravenously (IV) three times per week for 26 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo administered intravenously (IV) three times per week for 26 weeks; |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 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 regular maintenance hemodialysis three times a week for at least three months；
- 4.Dialysate calcium concentration≥1.25 mmol/L (2.5 mEq/L);
- 5.Diagnosed of Secondary Hyperparathyroidism (SHPT), with averaged iPTH ≥400 pg/ml14 days prior to screening;
Key exclusion criteria (7 listed)
- 1.The subjects underwent parathyroidectomy within 6 months prior to screening, or plan to undergo parathyroidectomy or ablation or radiation during the study;
- 2.Gastrointestinal bleeding or peptic ulcer medical history within 6 months prior to screening;
- 3.The body mass index of the subjects was less than 18kg/m2 or greater than 35 kg/m2;
- 4.Subjects with severe uncontrolled hypertension, defined as systolic blood pressure>180 mmHg and/or diastolic blood pressure>110 mmHg(Except for transient blood pressure abnormalities seen during dialysis), despite optimal drug treatment prior to enrollment;
- 5.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 dose regimen 1 |
| MT1013MT1013 is a novel calcimimetic agent | Drug | MT1013 dose regimen 2 |
| Etelcalcetide Hydrochloridethe already-marketed therapeutic agents | Drug | Etelcalcetide |
| PlaceboThe measure does not contain the active ingredients | Drug | Placebo |
Primary outcome
Percentage of participants with > 30% reduction from baseline in mean iPTH during the efficacy assessment phase
Time frame: Weeks 22 to 27, inclusive
1 secondary outcome
Percentage of participants with > 50% reduction from baseline in mean iPTH during the efficacy assessment phase
Time frame: Weeks 22 to 27, inclusive
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
Related trials for Secondary Hyperparathyroidism (SHPT) in Subjects With Chronic Kidney Disease (CKD) on Hemodialysis
RecruitingPhase 3
A Trial of Etelcalcetide in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis
Secondary Hyperparathyroidism, Chronic Kidney Disease
RecruitingPhase 2
Study of MT1013 Injection for the Treatment of Secondary Hyperparathyroidism (SHPT) Patients With Chronic Kidney Disease Undergoing Maintenance Dialysis
Secondary Hyperparathyroidism (SHPT) in Subjects With Chronic Kidney Disease (CKD) on Hemodialysis
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 and Etelcalcetide Hydrochloride 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 7 inclusion and 7 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: finished, as of the sponsor's last update on 22 Jul 2026. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants with > 30% reduction from baseline in mean iPTH during the efficacy assessment phase (time frame: Weeks 22 to 27, inclusive). 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 22 Jul 2026.