Study to Evaluate the Efficacy and Safety of MY008211A in Subjects with Primary Immunoglobulin a Nephropathy (IgAN)

Официальное название

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate the Efficacy and Safety of MY008211A in Subjects with Primary Immunoglobulin a Nephropathy (IgAN)

Обзор

Efficacy and safety of MY008211A in IgAN patients

Подробное описание

This was a multicenter, randomized, double-blind, dose-ranging, parallel-group study. Two doses of MY008211A (200mg, 400mg) were compared with placebo. The study comprised a screening period of this study for 90 days, an efficacy observation period for 24 weeks, a long-term study for 80 weeks, and a follow-up period for 2 weeks.

Вмешательства

• Препарат MY008211A tablets
  MY008211A BID
• Препарат MY008211A tablets matched placebo
  Matching placebo to MY008211A taken twice a day.

Первичные конечные точки

• The ratio of urine protein to creatinine concentration ratio (UPCR based on 24h urine collection, 24h-UPCR) relative to baseline at Week 12. [Срок оценки: Week 12]

Вторичные конечные точки (6)

• The ratio of 24 h-UPCR relative to baseline at each visit during treatment period except Week 12. [Срок оценки: up to 24 weeks]
• The ratio of 24-hour urine protein excretion (24 h-UPE) relative to baseline at each visit during treatment period. [Срок оценки: up to 24 weeks]
• The ratio of 24-hour urine albumin (24 h-UA) relative to baseline at each visit during treatment period. [Срок оценки: up to 24 weeks]
• The ratio of 24-hour urine albumin to creatinine concentration ratio (24 h-UACR) relative to baseline at each visit during treatment period. [Срок оценки: up to 24 weeks]
• Change from baseline in serum creatinine at each visit during treatment period. [Срок оценки: up to 24 weeks]
• Change from baseline in estimated glomerular filtration rate (eGFR) at each visit during treatment period. [Срок оценки: up to 24 weeks]

Критерии участия

Критерии включения

• Males or females ≥ 18 and ≤ 75 years of age at Screening.
• Estimated GFR(eGFR) ≥30 mL/min/1.73m2.
• Subjects with a biopsy-confirmed diagnosis of IgAN.
• Urine protein ≥0.75 g/24h from a 24h urine collection.
• All patients must have been on stable supportive care including a maximally tolerated dose or approved maximal dose of ACEi or ARB therapy for at least 90 days prior to the first administration of study drug.
• Subjects who received SGLT2i must have been on a stable treatment with the maximum allowed or tolerated dose prior to the first administration of study drug.
• Vaccination against Neisseria meningitidis(MenACWY) is required within 3 years.
• Vaccination for the prevention of S. pneumoniae is required within 5 years.

Критерии исключения

• Systolic blood pressure >130 mm Hg or diastolic blood pressure >80 mm Hg.
• Presence of any secondary IgAN.
• Presence of rapidly progressive glomerulonephritis.
• Presence of other chronic kidney diseases.
• Patients with a diagnosis of type 1 or type 2 diabetes mellitus.
• A history of invasive infections caused by encapsulated bacteria, e.g., meningococci or pneumococci.
• Patients previously treated with immunosuppressive agents exposure within 90 days prior to start of study drug dosing.
• Patients previously treated with traditional Chinese medicine containing immunosuppressive ingredients within 90 days prior to start of study drug dosing.
• Patients who had been treated with any systemic corticosteroids within the 180 days before treatment ≥20 mg/d for primary IgAN indication.
• Patients who previously have received biologic agent or monoclonal antibodies prior to start of study drug dosing within 5 half-lives or 30 days (whichever is longer).
• Patients who have received live/attenuated vaccines within the 4 weeks prior to randomization, or plan to receive during the trial.

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

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Peking University First Hospital — Пекин

Идентификаторы

NCT: NCT06687174 · MY008211A-IgAN-2-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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