2024-511067-29-00招募中3 期
A multi-center, randomized, double-blind, placebo-controlled, parallel group, phase III study to evaluate the efficacy and safety of LNP023 in primary IgA nephropathy patients
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 102
- 试验地点
- 37
- 主要终点
- Primary Endpoint for Interim Analysis: •Log-transformed ratio to baseline in UPCR (sampled from 24h urine collection) at 9 months.
研究概览
简要总结
Main Objective for Interim Analysis: •To demonstrate superiority of LNP023 vs. placebo in the reduction of proteinuria at 9 months by measuring UPCR sampled from a 24h urine collection. Main Objective for Final Analysis: •To demonstrate superiority of LNP023 vs. placebo in slowing IgAN progression measured by the annualized total slope of eGFR decline over 24 months.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Male and female patients ≥ 18 years of age with an eGFR level and biopsy-confirmed IgA nephropathy as follows: •For patients eGFR* ≥ 45ml/min/1.73m2, a qualifying biopsy performed within the last 5 years is required •For patients with eGFR* 30 to <45ml/min/1.73m2, a qualifying biopsy performed within 2 years with < 50% tubulointerstitial fibrosis is required. • For patients with eGFR* 20 to <30ml/min/1.73m2, a qualifying biopsy performed at any time. In all cases, if a historical biopsy is not available, one may be performed during screening. *eGFR calculated using the CKD-EPI formula (or modified MDRD formula according to specific ethnic groups and local practice guidelines).
- •Proteinuria due to primary diagnosis of IgA nephropathy as assessed at screening by UPCR ≥1 g/g (113 mg/mmol) sampled from FMV or 24h urine collection, as well as at the completion of the run-in period by UPCR ≥1 g/g (113 mg/mmol) calculated as the (geometric) mean of two 24h urine collections obtained within 14 days of each other at baseline.
- •Vaccination against Neisseria meningitidis and Streptococcus pneumoniae infection is required prior to the start of study treatment. If the patient has not been previously vaccinated, or if a booster is required, vaccine should be given according to local regulations at least 2 weeks prior to first study drug administration. If study treatment has to start earlier than 2 weeks post vaccination, prophylactic antibiotic treatment should be initiated.
- •If not previously vaccinated, vaccination against Haemophilus influenzae infections should be given, if available and according to local regulations, at least 2 weeks prior to first study drug administration.
- •All patients must have been on supportive care including stable dose regimen of ACEi or ARB at either the locally approved maximal daily dose or the maximally tolerated dose (per investigators' judgment) for approximately 90 days before first study drug administration. In addition, if patients are taking diuretics or other antihypertensive medication or other background medication for IgAN, the doses should also be stabilized for approximately -90 days prior to the first dosing of study treatment.
排除标准
- •Any secondary IgAN as defined by the investigator; secondary IgAN can be associated with cirrhosis, celiac disease, Human Immunodeficiency Virus (HIV) infection, herpetiformis, seronegative arthritis, small-cell carcinoma, lymphoma, disseminated tuberculosis, bronchiolitis obliterans, and inflammatory bowel disease, familial mediterranean fever, etc.
- •Sitting office SBP >140 mmHg or DBP >90 mmHg at the randomization visit.
- •Patients previously treated with immunosuppressive or other immunmodulatory agents such as but not limited to cyclophosphamide, rituximab, infliximab, eculizumab, canakinumab, hydroxychloroquine, mycophenolate mofetil (MMF) or mycophenolate sodium (MPS), cyclosporine, tacrolimus, sirolimus, everolimus, or systemic corticosteroids exposure (>7.5 mg/d prednisone/prednisolone equivalent) within 90 days (or 180 days for rituximab) prior to first study drug administration. Participants previously or currently treated with oral budesonide. Participants treated with endothelin (receptor) antagonists within 90 days prior to first study drug administration.
- •Prior use of LNP023 or prior enrollment in any other LNP023 clinical trial where study drug was taken, including matching placebo.
- •History of recurrent invasive infections caused by encapsulated organisms, such as meningococcus and pneumococcus.
- •Active systemic bacterial, viral (including COVID-19) or fungal infection within 14 days prior to study drug administration.
结局指标
主要结局
Primary Endpoint for Interim Analysis: •Log-transformed ratio to baseline in UPCR (sampled from 24h urine collection) at 9 months.
Primary Endpoint for Interim Analysis: •Log-transformed ratio to baseline in UPCR (sampled from 24h urine collection) at 9 months.
Primary Endpoint for Final Analysis: •Annualized total eGFR slope estimated over 24 months.
Primary Endpoint for Final Analysis: •Annualized total eGFR slope estimated over 24 months.
次要结局
- Secondary Endpoint for Interim Analysis: •Change from baseline in eGFR at 9 months.
- Secondary Endpoint for Interim Analysis: •Proportion of participants reaching UPCR (sampled from 24h urine collection) <1g/g at 9 months, without receiving CS/IS or other newly approved drugs or initiating new background therapy for treatment of IgAN or initiating Kidney Replacement Therapy (KRT).
- Secondary Endpoint for Interim Analysis: •Annualized total eGFR slope estimated over 12 months.
- Secondary Endpoint for Interim Analysis: •Change from baseline to 9 months in the fatigue scale measured by the FACIT-Fatigue questionnaire.
- Secondary Endpoint for Interim Analysis: •Safety endpoints (including adverse events/serious adverse events, safety laboratory parameters, vital signs) collected from baseline to 9 months.
- Secondary Endpoints for Final Analysis: •Time from randomization to first occurrence of composite kidney failure event, defined as reaching either: - sustained ≥30% decline in eGFR relative to baseline, or - sustained eGFR <15 mL/min/1.73m², or - maintenance dialysis, or - receipt of kidney transplant, or - death from kidney failure.
- Secondary Endpoints for Final Analysis: •Log-transformed ratio to baseline in UPCR (sampled from 24h urine collection) at 9 months.
- Secondary Endpoints for Final Analysis: •Proportion of participants reaching UPCR (sampled from 24h urine collection) <1g/g at 9 months without receiving CS/IS, or other newly approved drugs or initiating new background therapy for treatment of IgAN or initiating KRT.
- Secondary Endpoints for Final Analysis: •Change from baseline to 9 months in the fatigue scale measured by the FACIT-Fatigue questionnaire.
- Secondary Endpoints for Final Analysis: •Safety endpoints (including adverse events/serious adverse events, safety laboratory parameters, vital signs) collected from baseline to the End of Study (EOS).
研究者
Novartis Pharma Arzneimittel GmbH
Scientific
Novartis Pharma AG
研究点 (37)
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