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New Dual-Target drug aims to beat current therapy for kidney Patients' hormone problem

NCT ID NCT07122401

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This Phase 3 trial tests a new drug called MT1013 against an existing drug, cinacalcet, in 424 adults on dialysis who have secondary hyperparathyroidism (overactive parathyroid glands). The study aims to see if MT1013 better controls parathyroid hormone levels and improves bone health over 26 weeks. Participants are randomly assigned to receive either MT1013 or cinacalcet, and neither they nor their doctors know which they are getting.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
MT1013 (a new dual-target drug)
What this could lead to
If it works, MT1013 could offer a more effective or safer option than current treatments for controlling hormone levels in dialysis patients.
What could go wrong
This is an early Phase 3 trial, so results may not confirm superiority over cinacalcet. Side effects are possible, and the drug may not work for everyone.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 424 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Nov 2026

An estimate. End dates often move.

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. Participants capable of understanding written information ,willing to participate in, and provide a written informed consent; 2. Male or female, at least 18 years old, 18 kg/m\^2 ≤BMI≤35 kg/m\^2; 3. Receiving regular maintenance dialysis 3 times a week for at least 12 weeks prior to screening; 4. Dialysate calcium concentration≥1.25 mmol/L (2.5 mEq/L); 5. 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; 6. 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. Exclusion Criteria: 1. Underwent parathyroidectomy within 6 months prior to screening, or anticipated parathyroidectomy, ablation or radiation during the study; 2. Gastrointestinal bleeding or peptic ulcer medical history within 6 months prior to screening; 3. 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). 4. 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.). 5. 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). 6. History of seizure within 1 year prior to screening, or currently receiving treatment for seizure disorders; 7. Received oral cinacalcet or ivocalcet within 14 days prior to screening, or received Etelcalcetide injection treatment within 4 months prior to screening; 8. Any other condition that, in the Investigator's judgment, would make the subject unsuitable for participation in this study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Zhongshan Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, 200032, China

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