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New treatment option for Secondary Hyperparathyroidism, Chronic Kidney Disease
Official title Study of MT1013 for the Treatment of Patients With Secondary Hyperparathyroidism
ClinicalTrials.gov ID: NCT07122401
What this study is testing
What is MT1013?
MT1013 is an investigational medicine, being studied as a potential treatment for secondary hyperparathyroidism, chronic kidney disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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);
- people must have a confirmed diagnosis of Secondary Hyperparathyroidism (SHPT), with a mean pre-dialysis serum intact parathyroid hormone (iPTH)...
You likely can't join if
- 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...
- QTcF interval \>470 ms in males or \>480 ms in females on screening ECG, or other clinically significant ECG abnormalities as determined by the...
- people with severe uncontrolled hypertension during the screening period are excluded, defined as systolic blood pressure \>180 mmHg and/or diastolic...
- History of seizure within 1 year prior to screening, or currently receiving treatment for seizure disorders;
See the full eligibility criteria
- 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);
- people 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...
- Within 14 days prior to randomization, people 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...
- 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...
- people 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.