NCT06120673撤回3 期
International, Multi-centre Randomised Clinical Trial of Obinutuzumab Versus Corticosteroid and Cyclophosphamide in Primary Membranous Nephropathy (REMIT Trial).
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 入组人数
- 224
- 试验地点
- 13
- 主要终点
- A ranked composite measure based efficacy, safety and quality of life at 24 months
研究概览
简要总结
REMIT is an investigator-initiated, international, multi-centre, prospective, randomised, open-label, parallel-group trial. A total of 224 adult participants with Primary Membranous Nephropathy (PMN) will be recruited from renal units from Australia, New Zealand Canada, Asia, Europe, United Kingdom, and other countries. Participants will be randomised to receive either corticosteroid and cyclophosphamide or obinutuzumab. The primary outcome is a ranked, composite measure based on (a) efficacy, defined as either complete or partial remission of PMN, (b) number of adverse events, and (c) quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years.
- •Able to provide informed consent.
- •Primary Membranous Nephropathy (PMN) confirmed by:
- •Kidney biopsy (anti-PLA2R negative patients are eligible for inclusion if PMN is confirmed on biopsy. Kidney biopsy is generally encouraged to confirm diagnosis of PMN) or
- •if the clinician decides against a biopsy, the patient must be anti-PLA2R positive and must not have diabetes.
- •Proteinuria ≥4 g/24h despite supportive treatment for at least 6 months with maximally tolerated dose of ACE-i or ARB (dose to be stable for at least 4 weeks), confirmed at final screening before randomisation
- •Serum albumin <30 g/L.
- •Estimated glomerular filtration rate (eGFR) ≥40 ml/min/1.73m
- •Treatment with immunosuppression is warranted, as determined by the treating physician.
- •Fully vaccinated against COVID-19 according to local practice/recommendation.
排除标准
- •Resistant to rituximab or have had >2 g of rituximab in the past.
- •Resistant to cyclophosphamide or have had a cumulative >20 g of cyclophosphamide in the past.
- •More than 3 years since PMN diagnosis.
- •Proteinuria must not have decreased by >50% over 6 months whilst taking ACE-i/ARB.
- •Patients with human immunodeficiency virus (HIV) infection, active hepatitis B or C infection, or other active infections.
- •Patients with secondary membranous nephropathy
- •Screening for malignancy must be considered especially in cases who are anti-PLA2R negative.
- •Patients whose kidney biopsy shows concomitant features of diabetic nephropathy.
- •Kidney transplant recipients.
- •Pregnancy or breastfeeding.
- •Women of childbearing age not willing to use contraception.
- •Suspected or known hypersensitivity, allergy, and/or immunogenic reaction history to monoclonal antibodies, corticosteroid, cyclophosphamide, any of their ingredients, and any other drugs from these same pharmacotherapeutic groups.
- •Any disorder or condition, in the opinion of the investigator, might pose an unacceptable risk to participant's safety and well-being.
- •Inability to understand or comply with the requirements of the study.
- •Incapable of recognizing the nature, significance, and scope of the clinical trial or giving consent are excluded, even if they have a legal representative.
- •Use of an investigational agent <30 days or within five half-lives of the investigational agents (whichever is longer), whose effect or toxicity may overlap with that of obinutuzumab, prednisolone, cyclophosphamide, or their metabolites.
- •Active Tuberculosis infection. Testing for latent disease may be performed at screening if required by local regulations or in accordance with local clinical practice. Latent disease after completion of appropriate treatment is not exclusionary.
- •Low peripheral B-cell count (as per local reference range) . B-cell count must be checked, particularly in those who have received rituximab, cyclophosphamide or both anytime in the past.
- •Use of SGLT2-i and GLP-1 agonist within 90 days prior to randomisation.
研究组 & 干预措施
Obinutuzumab
Experimental
干预措施: Obinutuzumab (Drug)
Oral prednisolone and cyclophosphamide
Active Comparator
干预措施: Oral prednisolone and cyclophosphamide (Drug)
结局指标
主要结局
A ranked composite measure based efficacy, safety and quality of life at 24 months
时间窗: 24 months
A ranked composite measure comprising of: 1. Efficacy (complete/partial remission) plus safety (type of adverse event) at 24 months 2. Number of adverse events up to 24 months 3. Quality of Life (EQ-5D) averaged over 24 months
次要结局
- Number of participants in Partial Remission (PR)(At 6, 12, 18, 24 month)
- Number of participants with a lack of response to PMN treatment(Up until 24 months)
- Number of participants who relapse after CR or PR(Up until 24 months)
- Quality of life scores (EQ-5D-5L)(at 3, 6, 9, 12, 15, 18, 24 months)
- Number of participants in Complete Remission (CR)(At 6, 12, 18, 24 month)
- Number of participants in CR and/or PR(At 6, 12, 18, 24 month)
- Number of non-serious adverse events of special interest(Up until 24 months)
- Number of serious adverse events(Up until 24 months)
- eGRF slope(Up until 24 months)
- All cause deaths(Up until 24 months)
- Time to first relapse(Up until 24 months)
- Number of treatment or PMN associated deaths(Up until 24 months)
- Number of participants who have immunological remission (for anti-PLA2R positive participants)(Up until 24 months)
- Number of participants who have a requirement for rescue therapy(Up until 24 months)
- Number of participants who exit the trial(Up until 24 months)
研究者
研究点 (13)
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