A Study of SGB-9768 in Patients with Complement-mediated Kidney Diseases

Официальное название

A Phase 2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of SGB-9768 in Patients with Primary IgA Nephropathy, C3 Glomerulopathy, and Immune Complex-mediated Membranoproliferative Glomerulonephritis.

Обзор

This study looks at how well and safely SGB-9768 works for patients with certain kidney diseases: primary IgA nephropathy, C3 glomerulopathy, and immune complex-related membranoproliferative glomerulonephritis. It's a phase 2 trial done at several locations where both patients and doctors know what treatment is being given.

Подробное описание

This is a phase 2, multicenter, open-label study to evaluate of the efficacy and safety of SGB-9768 in patients with primary IgA nephropathy, C3 glomerulopathy, and immune complex-mediated membranoproliferative glomerulonephritis. The primary objective is to evaluate efficacy of SGB-9768 in reducing urine protein excretion and maintain kidney function in these patients. Secondly, safety, pharmacokinetics and pharmacodynamics will be charaterized.

Вмешательства

• Препарат SGB-9768
  SGB-9768 for subcutaneous (SC) injection

Первичные конечные точки

• change from baseline in urine protein-creatinine ratio (UPCR) [Срок оценки: 24 weeks]

Вторичные конечные точки (10)

• change from baseline in UACR and 24h-urine protein [Срок оценки: 24 weeks]
• change from baseline in estimated glomerular filtration rate (eGFR) [Срок оценки: 36 weeks]
• Number of Participants with Adverse Events (AEs) and/or Serious Adverse Events (SAEs) [Срок оценки: from erollment through week 36]
• Pharmacokinetics-Cmax [Срок оценки: 24 hours]
• Pharmacokinetics-Tmax [Срок оценки: 24 hours]
• Pharmacokinetics-AUClast [Срок оценки: 24 hours]
• Pharmacokinetics-t1/2 [Срок оценки: 24 hours]
• Pharmacodynamics-C3 [Срок оценки: baseline through week 36]
• Pharmacodynamics-complement classical pathway activity by Wieslab® CP [Срок оценки: baseline through week 36]
• Pharmacodynamics-complement alternative pathway activity by Wieslab® AP [Срок оценки: baseline through week 36]

Критерии участия

Критерии включения

• Aged ≥18 years
• Weight ≥40 kg, with a body mass index (BMI) between 15 and 35 kg/m²
• Biopsy-confirmed diagnosis of primary IgA nephropathy, C3 glomerulopathy or IC-MPGN, accompanied by C3 deposition in the glomeruli.
• Urine protein-to-creatinine ratio (UPCR) ≥0.75 g/g
• Estimated glomerular filtration rate (eGFR) (calculated using the CKD-EPI formula) must be ≥30 mL/min/1.73 m².
• Must be on a stable maximum tolerated doses of ACE inhibitors (ACEI) or angiotensin receptor blockers (ARB) for at least 12 weeks
• Participants of childbearing potential must use highly effective contraception during the study and for at least 12 weeks following the end of the study or last dose of study drug

Критерии исключения

• Kidney biopsy indicates more than 50% tubular atrophy or interstitial fibrosis.
• Kidney biopsy shows more than 50% formation of glomerular crescents, or clinical signs suggestive of rapidly progressive glomerulonephritis.
• IgA nephropathy, C3 glomerulopathy, or IC-MPGN secondary to other diseases
• Presence of other systemic diseases or kidney diseases that may cause proteinuria
• Received immunosuppressants or other immunomodulators within 90 days prior to the first administration of the investigational drug
• Received B-cell targeted biologics or other biologics within 180 days prior to the first administration of the investigational drug
• Used SGLT2 inhibitors or endothelin receptor antagonists, unless have been stably used for 12 weeks or more
• Significant comorbidities
• History of any malignant tumors of any organ system within the past 5 years
• History of severe trauma or major surgery within 12 weeks prior to screening, or plans to undergo surgery during the study.
• History of immunodeficiency diseases, congenital asplenia or splenectomy.
• History of recurrent invasive infections, active systemic bacterial, viral, or fungal infections
• Positive test results for HBV, HCV, HIV
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels > 2.5 times the upper limit of normal (ULN)

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 11 центров

• Peking University First Hospital — Пекин
• Peking University People's Hospital — Пекин
• The Third Xiangya Hospital of Central South University — Чанша
• Sichuan Provincial People's Hospital — Чэнду
• Guizhou Provincial People's Hospital — Guiyang
• The affiliated hospital of Guizhou medical university — Guiyang
• The first affiliated hospital, Zhejiang university school of medicine — Ханчжоу
• Huashan hospital — Шанхай
• … и ещё 3 центра

Идентификаторы

NCT: NCT06786338 · SGB-9768-003

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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