A Study of the Effect and Safety of HS-10390 in the Treatment of Patients with Primary IgA Nephropathy

Официальное название

A Randomized, Multicenter, Open-label, Active-control Study of the Efficacy and Safety of HS-10390 for the Treatment of Immunoglobulin a Nephropathy

Обзор

This study will evaluate the efficacy and safety of HS-10390 in subjects with primary IgA nephropathy, and explore the optimal dose for the treatment.

Вмешательства

• Препарат HS-10390
  HS-10390 will be administered daily
• Препарат Irbesartan
  Irbesartan will be administered daily as a 150-mg oral tablet. For patients who tolerate the initial dose of 150 mg after 2 weeks will increase their dose to 300 mg

Первичные конечные точки

• Change from baseline in 24-hour urine protein at Week 12 [Срок оценки: up to week 12]

Вторичные конечные точки (7)

• Change from baseline in 24-hour urine protein (UPCR) [Срок оценки: up to Week 12]
• Change from baseline in 24-hour urine protein(UACR) [Срок оценки: up to Week 12]
• Change from baseline in 24-hour urine protein [Срок оценки: up to Week 12]
• Proportion Change from baseline in 24-hour urine protein [Срок оценки: up to Week 12]
• change from baseline in Estimated Glomerular Filtration Rate [Срок оценки: up to Week 12]
• Number of subjects with adverse events (AEs) [Срок оценки: up to Week 12]
• Plasma Concentration of HS-10390 [Срок оценки: up to Week 12]

Критерии участия

Критерии включения

• Male or female, between 18 and 65 years age.
• Biopsy-proven primary IgA nephropathy.
• Currently on stable dose of ACEI and/or ARB therapy, for at least 12 weeks prior to screening (the patient's maximum tolerated dose and is at least one-half of the maximum labeled dose).
• Average 24-hour urine total protein ≥ 0.75 g/24 h at screening.
• Estimated GFR (using the CKD-EPI 2009) ≥ 30 mL/min per 1.73 m\^2 at screening.
• Systolic BP between 100 and 150 mmHg and diastolic BP between 60 and 100 mmHg.

Критерии исключения

• IgA nephropathy secondary to another condition
• IgA nephropathy with rapid decline of renal function; Kidney pathology indicated that more than 50% of the glomerulus had large crescent body formation, which may affect the study results; Tubule atrophy - interstitial fibrosis of more than 50%;
• Chronic kidney disease (CKD) in addition to IgAN
• Patients treated with any systemic non-biologic immunosuppressive drugs (including systemic corticosteroids) within 12 weeks prior to randomizing；
• Require any prohibited medications prior to randomizing;
• Exposure to an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to screening
• History of organ transplantation, with exception of corneal transplants
• Platelet< 100×109/L or hemoglobin value < 90 g/L) or Hematocrit value < 27% (0.27 V/V) at Screening
• Elevations of transaminases (ALT and/or AST) >2 times upper limit of normal or total bilirubin and/or direct bilirubin exceeding 1.5 times the upper limit of normal (ULN) at screening
• Potassium >5.5 mmol/L at Screening

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

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Peking University First Hospital — Пекин

Идентификаторы

NCT: NCT06635772 · HS-10390-201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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