FXS6837 for the Treatment for IgAN Patients（Longterm Study）

Официальное название

A Study to Evaluate the Long-term Efficacy and Safety of FXS6837 in IgAN Patients

Обзор

This is a multicenter, open-label study to evaluate the long-term safety and efficacy of FXS6837 capsules in primary IgAN patients. About 60 IgAN patients who had received and completed FXS6837-IIb-201 study treatment will be enrolled to take FXS6837 capsules orally according to protocol for 2 years.

Вмешательства

• Препарат FXS6837 Capsule
  FXS6837 capsule orally taken according to protocol for 2 years

Первичные конечные точки

• Incidence and severity of adverse events [Срок оценки: through study completion, an average of 2 years]

Вторичные конечные точки (8)

• Ratio of urine protein-to-creatinine ratio (UPCR) to baseline at each visit [Срок оценки: through study completion, an average of 2 years]
• Ratio of urine albumin-to-creatinine ratio (UACR) to baseline at each visit [Срок оценки: through study completion, an average of 2 years]
• Ratio of 24-h urine protein (24 hour-UPE) to baseline at each visit [Срок оценки: through study completion, an average of 2 years]
• Ratio of 24-h urine albumin excretion (24 hour-UAE) to baseline at each visit [Срок оценки: through study completion, an average of 2 years]
• Change from baseline in estimated glomerular filtration rate (eGFR) at each visit [Срок оценки: through study completion, an average of 2 years]
• Trough plasma concentration of FXS6837 [Срок оценки: through study completion, an average of 2 years]
• Complement AP activity in peripheral blood at each visit point [Срок оценки: through study completion, an average of 2 years]
• Levels and changes of PD biomarkers in plasma and urine at each visit [Срок оценки: through study completion, an average of 2 years]

Критерии участия

Inclusion criteria: 1. Have completed the study treatment in FXS6837-IIb-201, and are evaluated by the investigator to have an anticipated benefit exceeding risk with long-term FXS6837 treatment; 2. eGFR (CKD-EPI) ≥ 30 mL/min/1.73 m2 at screening; 3. Vaccinated against Neisseria meningitidis and Streptococcus pneumoniae as required by the previous study (Booster vaccination should be administered promptly in accordance with vaccination guidelines and local immunization authority requirements if the vaccine protection period fails to cover the treatment duration of this study); 4. Able to continue optimized treatment with RASi, SGLT2i, ERA, and hydroxychloroquine throughout the study with stable prescribed dosing; 5. Have a detailed understanding of the nature, significance, possible benefits, potential inconveniences, and potential risks of the trial, and voluntarily participate in this clinical trial; Able to communicate well with the investigators and comply with the requirements of the entire study; And signed a written ICF; 6. Participants of reproductive potential commit to having no plans for pregnancy or sperm/egg donation from screening until 1 month (female participants) or 3 months (male participants) after the last dose and voluntarily take effective physical contraceptive methods (including partners). Exclusion criteria: 1. Known or suspected by investigators to have immunodeficiency diseases or hereditary complement deficiency; 2. Any organ transplant recipients (except corneal transplant); 3. Concomitant major systemic diseases, including but not limited to: advanced heart disease (such as NYHA class IV), severe pulmonary disease (such as severe pulmonary hypertension \[WHO class IV\]), active hepatitis, or other major systemic diseases assessed by investigators as unable to participate in this study; 4. History of malignant tumors within 5 years before screening (except carcinoma in situ and thyroid cancer assessed by investigators as curatively resected).

5\. Previous history of Neisseria meningitidis or recurrent Streptococcus pneumoniae infection ; 6. Suspected or known history of allergies to similar ingredients of the study drug or any ingredient in the study drug; 7. Pregnant or lactating women or those with positive pregnancy test results; 8. Other conditions deemed by the investigator that may potentially interfere with study conduct, impose additional risks to the participant, or render the individual ineligible for study participation.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Peking University First Hospital — Пекин

Идентификаторы

NCT: NCT07750665 · FXS6837-IgAN-202

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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