New Dual-Target drug aims to beat current therapy for kidney Patients' hormone problem
NCT ID NCT07122401
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Chronic kidney disease are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
RECRUITINGShanghai, Shanghai Municipality, 200032, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a breathing workout and walks help dialysis patients with irregular heartbeats?
- Can AI-Tailored heat warnings shield chronic disease patients from dangerous temperatures?
- Can a Patient's own kidney cells hold off dialysis?
- A blood test at 50 could flag your risk of five diseases. can an app stop them?
- Two drugs, one goal: can finerenone or semaglutide cut kidney damage markers?
- One team, three conditions: can coordinated care tame heart, kidney, and diabetes?