EUCTR2017-000891-27-BE进行中（未招募）1 期
An adaptive seamless randomized, double-blind, placebo-controlled, dose ranging study to investigate the efficacy and safety of LNP023 in primary IgA nephropathy patients
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •? Female and male patients = 18 years of age with a biopsy-verified IgA nephropathy and where the biopsy was performed within the previous three years. If the most recent renal biopsy was performed more than three years ago, a new biopsy should be performed.
- •? Patients must weigh at least 35 kg to participate in the study, and must have a body mass index (BMI) within the range of 15 - 38 kg/m2. BMI =Body weight (kg) / [Height (m)]2
- •? Measured Glomerular Filtration Rate (GFR) or estimated GFR calculated using the CKD-EPI formula (or modified MDRD formula according with specific ethnic and local practice guidelines [Imai, et al, 2011]) =30 mL/min per 1.73 m2
- •UPCR =0.8 g/g (=90 mg/mmol) sampled from first morning avoid (FMV) or urine protein =0,.75 g/24hr from a 24 urine collection at screening and urine protein =0.75 g / 24h after a 24 h urine collection at the completion of the run- in period
- •? Vaccination against Neisseria meningitidis types A, C, Y and W-135 is required at least 4 weeks prior to first dosing with LNP023. Vaccination against N. meningitidis type B, S. pneumoniae and H. influenzae should be conducted if available and acceptable by local regulations, at least 4 weeks prior to first dosing with LNP023
- •? All patients must have been on supportive care including a maximally tolerated dose of ACEi or ARB therapy for the individual, antihypertensive therapy or diuretics for at least 90 days before dosing.
- •Other protocol defined inclusion criteria may apply.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 99
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •? Presence of crescent formation in =50% of glomeruli assessed on renal biopsy
- •? Patients previously treated with immunosuppressive agents such as cyclophosphamide, mycophenolate mofetil (MMF) or mycophenolate sodium, cyclosporine, tacrolimus, sirolimus, or systemic corticosteroids within 90 days prior to start of LNP023/Placebo dosing
- •? All transplanted patients (any organ, including bone marrow)
- •? History of immunodeficiency diseases, or a positive Human Immunodeficiency Virus (HIV; ELISA and Western blot) test result.
- •? Chronic infection with Hepatitis B (HBV) or Hepatitis C (HCV). A positive HBV surface antigen (HBsAg) test, or if standard local practice, a positive HBV core antigen test, excludes a patient. Patients with a positive HCV antibody test should have HCV RNA levels measured. Subjects with positive (detectable) HCV RNA should be excluded
- •? Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study. The Investigator should make this determination in consideration of the subject’s medical history and/or clinical or laboratory evidence of any of the following:
- •? ? A history of invasive infections caused by encapsulated organisms e.g. meningococcus or pneumococcus
- •? •? ?Splenectomy
- •? •? ?Inflammatory bowel disease, peptic ulcers, severe gastrointestinal disorder including rectal bleeding;
- •? Major gastrointestinal tract surgery such as gastrectomy,
- •gastroenterostomy, or bowel resection;
- •? •? Pancreatic injury or pancreatitis;
- •? •? Liver disease or liver injury as indicated by abnormal liver function tests. ALT (SGPT), AST (SGOT), GGT, alkaline phosphatase and
- •serum bilirubin will be tested.
- •? •? Any single parameter of ALT, AST, GGT, alkaline phosphatase or serum bilirubin must not exceed 3 x upper limit of normal (ULN)
- •? •? Prothrombin Time / International normalized ration (PT/INR) must be within the reference range of normal individuals
- •Evidence of urinary obstruction or difficulty in voiding any urinary tract disorder other than IgAN that is associated with hematuria at screening; [If necessary, laboratory testing may be repeated on one occasion (as soon as possible) prior to randomization, to rule out any laboratory error]
- •? Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test.
- •? A history of clinically significant electrocardiogram (ECG)abnormalities, or any of the following ECG abnormalities at screening or baseline:
- •? •? PR > 200 msec
- •? •? QRS complex > 120 msec
- •?•? QTcF > 450 msec (males)
- •? •? QTcF > 460 msec (females)
- •? History of familial long QT syndrome or known family history of Torsades de Pointes
- •? Use of agents known to prolong the QT interval unless they can be permanently discontinued for the duration of the study
- •? History of severe allergic reactions as per Investigator decision
- •? Female patients who are pregnant or breastfeeding, or intending to conceive during the course of the study
- •? Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception from first dosing with LNP023 until an additional one week f
研究者
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