Obinutuzumab in Treatment of Fibrillary Glomerulonephritis

Официальное название

A Single-Center Phase 2 Open-Label Trial Evaluating the Efficacy and Safety of Obinutuzumab in Treatment of Fibrillary Glomerulonephritis

Обзор

The purpose of this research is to learn if Obinutuzumab is effective and safe in treating patients with fibrillary glomerulonephritis (FGN).

Вмешательства

• Препарат Obinutuzumab
  Obinutuzumab 1g IV on day one and 1 g IV on day 15, followed by identical course at month 6.

Первичные конечные точки

• Change in proteinuria from baseline to 12 months post treatment with Obinutuzumab [Срок оценки: Baseline, 6 months, 12 months]

Вторичные конечные точки (5)

• Change in proteinuria from baseline to 6 months post treatment with Obinutuzumab [Срок оценки: Baseline, 6 months]
• Rate of complete or partial remission [Срок оценки: 6 months, 12 months]
• Improvement in serum albumin [Срок оценки: Baseline, 6 months, 12 months]
• Stabilization of kidney function [Срок оценки: Baseline, 6 months, 12 months]
• Serious Adverse Events (SAEs) [Срок оценки: Day 1-12 months]

Критерии участия

Критерии включения

• ≥18 years of age
• Biopsy proven fibrillary glomerulonephritis
• Proteinuria > 1.0 g/24hrs prior to initiation of immunosuppressive therapy
• eGFR ≥ 20 ml/min/BSA

Критерии исключения

• Secondary FGN (due to monoclonal gammopathy, autoimmune disease or malignancy)
• Presence of a secondary pathology on biopsy (e.g. diabetic nephropathy)
• Hepatitis B, C or HIV positive
• Pregnant or breast-feeding
• Active infection
• Kidney transplant
• Anemia with Hgb < 8.0 g/dL
• Thrombocytopenia with platelet count < 100'000
• Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complication
• Patients who have received cyclophosphamide in the last 6 months
• Patients who have received ACTH and/or mycophenolate mofetil in the last 30 days
• Patient who are on prednisone therapy at a dose > 10 mg/day in the last 15 days
• Patients who received rituximab previously with CD20 count of < 5 cells/microliter at the time of enrollment
• For women who are not postmenopausal (greater than or equal to \[>/=\] 12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use two adequate methods of contraception, including at least one method with a failure rate of less than (<) 1 percent (%) per year, during the treatment period and for at least 18 months after the last dose of study drug
• For men: agreement to remain abstinent or use two adequate methods for contraception, including at least one method with failure rate of less than 1% per year during the treatment period and for at least 6 months (180 days) after the last dose of drug

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

США · 1 центр

• Mayo Clinic — Rochester

Идентификаторы

NCT: NCT06295770 · 23-006712

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗