EUCTR2017-000889-29-GB进行中（未招募）1 期
An open-label, non-randomized study on efficacy, pharmacokinetics, pharmacodynamics, safety and tolerability of LNP023 in two patient populations with C3 glomerulopathy
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 27
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
- •Patients (females and males 18 years or older in age) must have C3G as confirmed by renal biopsy within twelve months prior to enrollment (confirmation by the Investigator is required).
- •C3G patients with reduced C3 at screening (defined as less than 0.90 x lower limit of the lab normal ranges) are eligible for this study.
- •Estimated GFR (using the CKD-EPI formula) =30 mL/min per 1.73 m2 for patients on a maximum recommended or maximum tolerated dose of an angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB).
- •UPCR = 100 mg/mmol sampled from first morning void (or = 1 g/24h total urinary protein excretion from a 24h urinary collection during runin) at run-in (Visit 20) or at baseline (Visit 30).
- •Any antiproteinuric medication (e.g., angiotensin converting enzyme inhibitors, angiotensin II receptor blockers) must be at a stable dose for at least 30 days prior to treatment start.
- •Previous vaccination against Neisseria meningitidis is required at least 4 weeks prior to first dosing with LNP023 (existing vaccinations should not have taken place more than 3 years prior to LNP treatment). If
- •LNP023 treatment has to start earlier than 4 weeks post last vaccination dose, prophylactic antibiotic treatment must be initiated.
- •Previous vaccination for the prevention of S. pneumoniae and H. influenzae at least 4 weeks prior to first dosing with LNP023 (existing vaccinations should not have taken place more than 3 years prior to LNP
- •treatment). If LNP023 treatment has to start earlier than 4 weeks post last vaccination dose, prophylactic antibiotic treatment must be initiated.
- •Patients (females and males 18 years or older in age) must have C3G
- •recurrence after transplantation as confirmed by renal biopsy after
- •transplantation within twelve months prior to enrollment (confirmation
- •by the Investigator is required).
- •Estimated GFR (using the CKD-EPI formula) =30 mL/min per 1.73 m2
- •Normal or elevated urinary protein excretion at screening or at baseline (Visit 30).
- •Previous vaccination against Neisseria meningitidis is required at least 4 weeks prior to first dosing with LNP023 (existing vaccinations should not have taken place more than 3 years prior to LNP treatment). If LNP023 treatment has to start earlier than 4 weeks post last vaccination dose, prophylactic antibiotic treatment must be initiated.
- •Previous vaccination for the prevention of S. pneumoniae and H. influenzae at least 4 weeks prior to first dosing with LNP023 (existing vaccinations should not have taken place more than 3 years prior to LNP treatment). If LNP023 treatment has to start earlier than 4 weeks post last vaccination dose, prophylactic antibiotic treatment must be initiated.
- •If applicable, induction treatment after allotransplantation needs to be completed >30 days before inclusion. Any commercially available
- •induction agent is permitted.
- •Patients need to be on a stable dose of immunosuppressive regimen
- •prior to Day 1. Any commercially available treatments are allowed for
- •this purpose.(if not prohibited as per protocol)
- •Transplantation of a kidney allograft >30 days before screening
- •No histologic signs of allorejection
- •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 24
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 3
排除标准
- •Known family history or known presence of long QT syndrome or Torsades de Pointes.
- •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 hCG laboratory test
- •Donation or loss of 400 mL or more of blood within eight (8) weeks prior to initial dosing, or longer if required by local regulation.
- •Plasma donation (>200 mL) within 30 days prior to first dosing.
- •Patients who cannot receive vaccinations against N. meningitidis, S. pneumoniae, or H. influenzae.
- •Use of other investigational drugs at the time of enrollment, or within 5 half-lives, or within 30 days of screening, whichever is longer; or longer if required by local regulations.
- •Known family history or known presence of long QT syndrome or Torsades de Pointes.
- •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 hCG laboratory test.
- •Donation or loss of 400 mL or more of blood within eight (8) weeks prior to initial dosing, or longer if required by local regulation.
- •Plasma donation (>200 mL) within 30 days prior to first dosing.
- •Patients who cannot receive vaccinations against N. meningitidis, S. pneumoniae, or H. influenzae.
- •Use of other investigational drugs at the time of enrollment, or within 5 half-lives, or within 30 days of screening, whichever is longer; or longer if required by local regulations.
研究者
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