Secondary Hyperparathyroidism, Chronic Kidney DiseasePhase 3NCT07122401
Study of MT1013 for the Treatment of Patients With Secondary Hyperparathyroidism
A Phase 3 study testing MT1013 and Cinacalcet in people with Secondary Hyperparathyroidism, Chronic Kidney Disease, run by Shaanxi Micot Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial summary
MT1013 is a first-in-class dual-target agonist. This study is a multicenter, randomized, double-blind, double-dummy phase III clinical study being conducetd to evaluate the efficacy and safety of MT1013 compared with active control cinacalcet in secondary hyperparathyroidism patients on maintenance dialysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Secondary Hyperparathyroidism, Chronic Kidney Disease
- What is being tested?
- MT1013 and Cinacalcet
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 424 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2025to 26 Nov 2026
- Phase
- Phase 3
- 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
- Participants capable of understanding written information ,willing to participate in, and provide a written informed consent;
- Male or female, at least 18 years old, 18 kg/m^2 ≤BMI≤35 kg/m^2;
- Receiving regular maintenance dialysis 3 times a week for at least 12 weeks prior to screening；
- Dialysate calcium concentration≥1.25 mmol/L (2.5 mEq/L);
- Subjects must have a confirmed diagnosis of Secondary Hyperparathyroidism (SHPT), with a mean pre-dialysis serum intact parathyroid hormone (iPTH) level ≥ 400 pg/mL (42.4 pmol/L), based on measurements from two non-consecutive days before dialysis, within 14 days prior to randomization;
- Within 14 days prior to randomization, subjects must have serum calcium levels (measured pre-dialysis, or corrected serum calcium if albumin <40 g/L) ≥ 8.4 mg/dL (2.1 mmol/L) on two non-consecutive pre-dialysis measurements.
Who cannot join
- Underwent parathyroidectomy within 6 months prior to screening, or anticipated parathyroidectomy, ablation or radiation during the study;
- Gastrointestinal bleeding or peptic ulcer medical history within 6 months prior to screening;
- New York Heart Association (NYHA) Class III or IV heart failure within 3 months prior to screening; Symptomatic arrhythmia within 6 months prior to screening; History of torsades de pointes (TdP).
- QTcF interval >470 ms in males or >480 ms in females on screening ECG, or other clinically significant ECG abnormalities as determined by the Investigator (e.g., third-degree atrioventricular block, sick sinus syndrome, multifocal frequent ventricular premature contractions, ventricular tachycardia, atrial fibrillation, etc.).
- Subjects with severe uncontrolled hypertension during the screening period are excluded, defined as systolic blood pressure >180 mmHg and/or diastolic blood pressure >110 mmHg despite optimal medical therapy prior to enrollment (excluding transient blood pressure abnormalities during dialysis).
- History of seizure within 1 year prior to screening, or currently receiving treatment for seizure disorders;
- Received oral cinacalcet or ivocalcet within 14 days prior to screening, or received Etelcalcetide injection treatment within 4 months prior to screening;
- Any other condition that, in the Investigator's judgment, would make the subject unsuitable for participation in this study.
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
Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
About this study
Official title: A Multicenter, Randomized, Double-blind, Double-dummy, Phase III Study to Evaluate the Efficacy and Safety of MT1013 Versus Cinacalcet as Active Control in Secondary Hyperparathyroidism Patients on Maintenance Dialysis
MT1013 is a first-in-class dual-target agonist. This study is a multicenter, randomized, double-blind, double-dummy phase III clinical study being conducetd to evaluate the efficacy and safety of MT1013 compared with active control cinacalcet in secondary hyperparathyroidism patients on maintenance dialysis. Subjects will be 1:1 randomized to receive MT1013 or cinacalcet for 26 weeks. Evaluations of iPTH, Ca, P, BMD, and biomarkers will be done across the study period, to compare efficacy and safety of MT1013 to cinacalcet.
- Being tested
- MT1013, Cinacalcet
- Medical subject headings
- Hyperparathyroidism, Secondary, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT1013Drug
MT1013 + dummy cinacalcet
CinacalcetDrug
Cinacalcet + dummy MT1013
| Study group | Role | What they receive |
|---|---|---|
| MT1013 | Experimental | MT1013 is administered intravenously (IV) for 26 weeks; Dummy cinacalcet will be administered orally for 26 weeks. Receives: Drug: MT1013 |
| Cinacalcet | Active comparator | Cinacalcet is administered orally for 26 weeks. Dummy MT1013 is administered intravenously (IV) for 26 weeks. Receives: Drug: Cinacalcet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with > 50% reduction from baseline in mean intact parathyroid (iPTH)
Measured: EAP（Week 22-27）
Percentage of participants with > 30% reduction from baseline in mean iPTH
Measured: EAP（Week 22-27）
Secondary outcomes (4)
Change From Baseline in Bone Mineral Density
Measured: Week 27
Change from baseline in serum calcium
Measured: EAP（Week 22-27）
Change From Baseline in serum phosphorus
Measured: EAP（Week 22-27）
Safety and Tolerance
Incidence and severity of TEAE/TESAE
Measured: Up to Week 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start30 Sep 2025
- Primary completion26 Nov 2026 (estimated)
- Study completion26 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Secondary Hyperparathyroidism, Chronic Kidney DiseaseStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 424 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
- NCT07122401
- Sponsor's protocol ID
- MT1013-III-C01
- Status last verified
- Nov 2026
- First submitted
- 1 Aug 2025
- Last updated
- 5 Nov 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 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Double-dummy, Phase III Study to Evaluate the Efficacy and Safety of MT1013 Versus Cinacalcet as Active Control in Secondary Hyperparathyroidism Patients on Maintenance Dialysis
- ClinicalTrials.gov ID
- NCT07122401
- Acronym / sponsor ID
- MT1013-III-C01
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 424 participants (estimated)
- Lead sponsor
- Shaanxi Micot Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Sep 2025 (actual)
- Primary completion
- 26 Nov 2026 (estimated)
- Study completion
- 26 Nov 2026 (estimated)
- First posted
- 14 Aug 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.
MT1013 is a first-in-class dual-target agonist. This study is a multicenter, randomized, double-blind, double-dummy phase III clinical study being conducetd to evaluate the efficacy and safety of MT1013 compared with active control cinacalcet in secondary hyperparathyroidism patients on maintenance dialysis. Subjects will be 1:1 randomized to receive MT1013 or cinacalcet for 26 weeks. Evaluations of iPTH, Ca, P, BMD, and biomarkers will be done across the study period, to compare efficacy and safety of MT1013 to cinacalcet.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MT1013 | Experimental | Drug: MT1013MT1013 is administered intravenously (IV) for 26 weeks; Dummy cinacalcet will be administered orally for 26 weeks. |
| Cinacalcet | Active comparator | Drug: CinacalcetCinacalcet is administered orally for 26 weeks. Dummy MT1013 is administered intravenously (IV) 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 (6 listed)
- Participants capable of understanding written information ,willing to participate in, and provide a written informed consent;
- Male or female, at least 18 years old, 18 kg/m^2 ≤BMI≤35 kg/m^2;
- Receiving regular maintenance dialysis 3 times a week for at least 12 weeks prior to screening；
- Dialysate calcium concentration≥1.25 mmol/L (2.5 mEq/L);
- Subjects must have a confirmed diagnosis of Secondary Hyperparathyroidism (SHPT), with a mean pre-dialysis serum intact parathyroid hormone (iPTH) level ≥ 400 pg/mL (42.4 pmol/L), based on measurements from two non-consecutive days before dialysis, within 14 days prior to randomization;
Key exclusion criteria (8 listed)
- Underwent parathyroidectomy within 6 months prior to screening, or anticipated parathyroidectomy, ablation or radiation during the study;
- Gastrointestinal bleeding or peptic ulcer medical history within 6 months prior to screening;
- New York Heart Association (NYHA) Class III or IV heart failure within 3 months prior to screening; Symptomatic arrhythmia within 6 months prior to screening; History of torsades de pointes (TdP).
- QTcF interval >470 ms in males or >480 ms in females on screening ECG, or other clinically significant ECG abnormalities as determined by the Investigator (e.g., third-degree atrioventricular block, sick sinus syndrome, multifocal frequent ventricular premature contractions, ventricular tachycardia, atrial fibrillation, etc.).
- Subjects with severe uncontrolled hypertension during the screening period are excluded, defined as systolic blood pressure >180 mmHg and/or diastolic blood pressure >110 mmHg despite optimal medical therapy prior to enrollment (excluding transient blood pressure abnormalities during dialysis).
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 + dummy cinacalcet | Drug | MT1013 |
| CinacalcetCinacalcet + dummy MT1013 | Drug | Cinacalcet |
Primary outcome
Percentage of participants with > 50% reduction from baseline in mean intact parathyroid (iPTH)
Time frame: EAP（Week 22-27）
Percentage of participants with > 30% reduction from baseline in mean iPTH
Time frame: EAP（Week 22-27）
4 secondary outcomes
Change From Baseline in Bone Mineral Density
Time frame: Week 27
Change from baseline in serum calcium
Time frame: EAP（Week 22-27）
Change From Baseline in serum phosphorus
Time frame: EAP（Week 22-27）
Safety and Tolerance
Time frame: Up to Week 30
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 5 Nov 2026.
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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 3 study testing MT1013 and Cinacalcet in people with Secondary Hyperparathyroidism, Chronic Kidney Disease, 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 6 inclusion and 8 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 5 Nov 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Xiaoqiang Ding, MD (021-31587862, DING.XIAOQIANG@ZS-HOSPITAL.SH.CN), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants with > 50% reduction from baseline in mean intact parathyroid (iPTH) (time frame: EAP（Week 22-27）). The study lists 2 primary outcomes in all. 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 5 Nov 2026.