FXS6837 for the Treatment of IgAN Patients

Официальное название

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of FXS6837 in IgAN Patients

Обзор

This is a multicenter, randomized, double-blind, placebo controlled Phase IIb study to explore the efficacy and safety of FXS6837 capsules in IgAN patients. About 60 patients dignosed with primary IgAN will be enrolled and randomized to three cohorts and take different dosage of FXS6837 or placebo capsules orally according to protocol.

Подробное описание

This is a multicenter, randomized, double-blind, placebo-controlled study in approximately 60 patients with primary IgA nephropathy (IgAN).

Participants receiving background therapy will be randomized in a 1:1:1 ratio to receive FXS6837 capsules dose 1,dose 2, or placebo, administered orally once daily.

The study aims to evaluate the efficacy and safety of FXS6837 in patients with primary IgAN and to identify the optimal clinical dose.

Вмешательства

• Препарат FXS6837 Dose 1
  FXS6837 taken orally once a day
• Препарат FXS6837 Dose 2
  FXS6837 taken orally once a day
• Препарат Placebo Capsule
  Placebo taken orally once a day

Первичные конечные точки

• Ratio to baseline in Urine Protein to Creatinine Ratio (sampled from 24h urine collection) at Day180 [Срок оценки: baseline and Day180]

Вторичные конечные точки (7)

• Ratio to baseline in Urine Protein to Creatinine Ratio at Day90 [Срок оценки: baseline and Day90]
• Ratio to baseline in Urine Protein to Creatinine Ratio [Срок оценки: up to Day180]
• Ratio to baseline in Urine Albumin to Creatinine Ratio [Срок оценки: up to Day180]
• Ratio to baseline in Urinary protein excretion（UPE） [Срок оценки: up to Day180]
• Ratio to baseline in Urinary Albumin excretion（UAE） [Срок оценки: up to Day180]
• Change from baseline of serum creatinine [Срок оценки: up to Day180]
• Change from baseline of estimated glomerular filtration rate（eGFR） [Срок оценки: up to Day180]

Критерии участия

Критерии включения

• Adult male or female patients aged ≥18 years with biopsy-confirmed primary IgA nephropathy (IgAN), meeting all of the following:

• A qualifying renal biopsy performed within the past 8 years;
• ≤50% tubulointerstitial fibrosis;
• Crescent formation present in ≤50% of glomeruli;
• If a historical biopsy is not available, a biopsy may be performed during screening.
• Estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m² at screening and at the end of the run-in period.
• Urine protein-to-creatinine ratio (UPCR) ≥0.75 g/g at screening and at the end of the run-in period.
• Vaccination against Neisseria meningitidis and Streptococcus pneumoniae is required prior to initiation of study treatment. If not previously vaccinated or if a booster is required, 5. vaccination should be administered according to local regulations at least 2 weeks prior to first dose. If treatment must begin earlier, prophylactic antibiotic therapy should be initiated.
• Patients must have received a stable dose of angiotensin-converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARB), at the locally approved maximum daily dose or maximally tolerated dose (per investigator judgment), for at least 90 days prior to first dose. If receiving sodium-glucose cotransporter-2 inhibitors (SGLT2i), endothelin receptor antagonists (ERA), or hydroxychloroquine, doses must also be stable for at least 90 days prior to first dose (per investigator judgment).

Критерии исключения

• Secondary IgA nephropathy (IgAN), as defined by the investigator.
• Rapidly progressive IgAN, defined as ≥50% decline in eGFR (CKD-EPI) within 3 months, or <50% decline but considered by the investigator to be at risk of rapid renal function deterioration.
• Other systemic diseases associated with proteinuria or chronic kidney disease (e.g., diabetic nephropathy, lupus nephritis, ANCA-associated vasculitis), or severe urinary tract obstruction or dysuria.
• Prior treatment with immunosuppressive agents, including but not limited to cyclophosphamide, rituximab, infliximab, eculizumab, canakinumab, mycophenolate mofetil (MMF), mycophenolate sodium (MPS), cyclosporine, tacrolimus, sirolimus, everolimus, or systemic corticosteroids within 90 days (or 5 half-lives, whichever is longer) prior to first dose.
• Prior treatment with oral budesonide (Nefecon®) within 6 months prior to first dose.
• Prior treatment with other complement inhibitors within 30 days (or 5 half-lives, whichever is longer) prior to first dose.
• Positive test results for HIV; active syphilis infection; chronic hepatitis B infection (HBsAg positive with HBV DNA > lower limit of quantification \[LOQ\]); or hepatitis C infection (positive HCV antibody with detectable HCV RNA).
• Active tuberculosis at screening.
• Clinically significant abnormal liver function at screening, defined as any of the following: ALT, AST, GGT, or ALP >3 × upper limit of normal (ULN), or total bilirubin >2 × ULN.
• History of meningococcal infection.
• Active systemic bacterial, viral (including COVID-19), or fungal infection within 14 days prior to first dose, or body temperature >38°C within 7 days prior to first dose.

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

• Peking University First Hospital — Пекин

Идентификаторы

NCT: NCT07502638 · FXS6837-IIb-201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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