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Идёт набор NCT07122401

Study of MT1013 for the Treatment of Patients With Secondary Hyperparathyroidism

Фаза III С лечением Secondary Hyperparathyroidism, Chronic Kidney Disease

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: MT1013, Cinacalcet.
Кому может быть актуально
Состояния в реестре: Secondary Hyperparathyroidism, Chronic Kidney Disease. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
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Официальное название

A Multicenter, Randomized, Double-blind, Double-dummy, Phase III Study to Evaluate the Efficacy and Safety of MT1013 Versus Cinacalcet as Active Control in Secondary Hyperparathyroidism Patients on Maintenance Dialysis

Обзор

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. Subjects will be 1:1 randomized to receive MT1013 or cinacalcet for 26 weeks. Evaluations of iPTH, Ca, P, BMD, and biomarkers will be done across the study period, to compare efficacy and safety of MT1013 to cinacalcet.

Вмешательства

  • Препарат MT1013
    MT1013 + dummy cinacalcet
  • Препарат Cinacalcet
    Cinacalcet + dummy MT1013

Первичные конечные точки

  • Percentage of participants with > 50% reduction from baseline in mean intact parathyroid (iPTH) [Срок оценки: EAP（Week 22-27）]
  • Percentage of participants with > 30% reduction from baseline in mean iPTH [Срок оценки: EAP（Week 22-27）]
Вторичные конечные точки (4)
  • Change From Baseline in Bone Mineral Density [Срок оценки: Week 27]
  • Change from baseline in serum calcium [Срок оценки: EAP（Week 22-27）]
  • Change From Baseline in serum phosphorus [Срок оценки: EAP（Week 22-27）]
  • Safety and Tolerance [Срок оценки: Up to Week 30]

Критерии участия

Критерии включения

  • 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);
  • 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;
  • 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.

Критерии исключения

  • 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 syndrome, multifocal frequent ventricular premature contractions, ventricular tachycardia, atrial fibrillation, etc.).
  • 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).
  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Четверное слепое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Zhongshan Hospital — Шанхай

Идентификаторы

NCT: NCT07122401 · MT1013-III-C01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗