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RecruitingNCT06976177Updated May 16, 2025

Study of MT1013 Injection for the Treatment of Secondary Hyperparathyroidism (SHPT) Patients With Chronic Kidney Disease Undergoing Maintenance Dialysis

A Phase 2 interventional study of MT1013 in Secondary Hyperparathyroidism (SHPT) in Subjects With Chronic Kidney Disease (CKD) on Hemodialysis, sponsored by Shaanxi Micot Technology Limited Company. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-16.

Sponsored by Shaanxi Micot Technology Limited Company · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 2 months ago, but the record still lists the study as recruiting.
  • Registered 11 months after the study started (first participant enrolled Jun 2024, registered May 2025).
  • Started Jun 2024; still recruiting 2 years 5 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
310
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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 for Part B study is 26 weeks.

02

Conditions studied

  • Secondary Hyperparathyroidism (SHPT) in Subjects With Chronic Kidney Disease (CKD) on Hemodialysis
03

In context

Hyperparathyroidism, Secondary

188 studies on the registry are indexed under Hyperparathyroidism, Secondary; 15 are open to participants now.

This study's planned enrollment of 310 is above the median of 62 across 146 interventional studies indexed under Hyperparathyroidism, Secondary.

Browse Hyperparathyroidism, Secondary studies →

Lead sponsor

Shaanxi Micot Technology Limited Company is the lead sponsor of 6 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

    1. Subject capable of understanding written information ,willing to participate in, and provide a written ; 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 criteria

Exclusion Criteria:

  • 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 drug; 8.History of epileptic seizures or ongoing epilepsy related treatment within 1 year prior to screening;
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
310 participants (estimated)

Study arms

  • Experimental
    MT1013

    MT1013 injection administered intravenously (IV) three times per week for 52(Part A) or 26(Part B) weeks

    Drug: MT1013

Interventions

  • DrugMT1013

    MT1013 is a novel calcimimetic agent

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Baseline up to 26 weeks

Secondary outcomes

  1. Percentage of participants with iPTH during 150-300pg/mL at week 26

    Time frame: at week 26

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06976177
Lead sponsor
Shaanxi Micot Technology Limited Company
Responsible party
Sponsor
First posted
May 16, 2025
Start date
Jun 7, 2024
Primary completion
Aug 19, 2025 (estimated)
Completion
Dec 12, 2025 (estimated)
Last update
May 16, 2025

Study contacts

Jiang hua Chen, MD
Contact
chenjianghua@zju.edu.cn
0571-87236844

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: MT1013

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