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New injection shows promise for dialysis patients with hormone imbalance

NCT ID NCT06690242

Disease control Sponsor: Shaanxi Micot Pharmaceutical Technology Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 23, 2026 · Updated 2 times

Summary

This study tested a new drug called MT1013 in 115 adults with chronic kidney disease who are on dialysis and have a condition called secondary hyperparathyroidism (high parathyroid hormone). The goal was to see if the drug could safely lower hormone levels by at least 30%. Participants received either MT1013, an active comparator, or a placebo. The results help determine if MT1013 could be a future treatment option for managing this hormone imbalance.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

115 people

The number who actually took part.

Started

Nov 2024

Finished

Aug 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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; Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

chronic kidney disease secondary hyperparathyroidism

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Secondary hyperparathyroidism (SHPT) in subjects with chronic kidney disease (CKD) on hemodialysis

Contacts and locations

Locations

  • First Affiliated Hospital College of Medicine, Zhejiang University

    Hangzhou, Zhejiang, 310003, China

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