NL-OMON56184招募中3 期
A multi-center, randomized, double-blind, placebocontrolled, parallel group, phase III study to evaluate the efficacy and safety of LNP023 in primary IgA nephropathy patients - CLNP023A2301 (APPLAUSE)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- ovartis
- 入组人数
- 3
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •Male and female patients >= 18 years of age with an eGFR level and
- •biopsy-confirmed IgA nephropathy as follows
- •o For patients eGFR* >= 45mL/min/1.73m2, a qualifying biopsy performed within
- •the last 5 years is required
- •o For patients with eGFR* 30 to <45mL/min/1.73m2, a qualifying biopsy performed
- •within 2 years with < 50% tubulointerstitial fibrosis is required
- •o 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.
- •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
- •infection 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, 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, dermatitis 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, 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.
研究者
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