EUCTR2017-000889-29-ES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
ovartis Farmacéutica, S.A.0 个研究点目标入组 27 人开始时间: 2018年11月5日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 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
- •Cohort A and B:
- •- Written informed consent must be obtained before any assessment is performed
- •- Male and female patients between the ages of 18 to 65 (inclusive) at screening
- •- C3G patients with proteinuria
- •- Able to communicate well with the investigator, to understand and comply with the requirements of the study
- •- At screening and baseline visits, patients must weigh at least 35 kg
- •- Supine vital signs should be within the following ranges: oral body temperature between 35.0-37.5 °C systolic blood pressure, 80-170 mm Hg diastolic blood pressure, 50-105 mm Hg pulse rate, 45 - 100 bpm .
- •- Estimated GFR (using the CKD-EPI formula) or measured GFR =30mL/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 (equivalent to = 1 g/24h total urinary protein excretion)
- •- Prior to entry, all patients must have been on supportive care including a maximally tolerated dose of ACEi or ARB for at least 30 days.
- •- No histological/laboratory/clinical signs of allorejection
- •- If applicable, induction treatment after allotransplantation needs to be completed >30 days before inclusion.
- •- Transplantation of a kidney allograft >90 days before inclusion
- •- Patients need to be on a stable dose of immunsuppressive regimen prior to inclusion. Any approved treatments are allowed for this purpose.
- •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
- •Cohort A and B:
- •- Use of other investigational drugs at the time of enrollment, or within 5 half-lives of randomization, or within 30 days, whichever is longer; or longer if required by local regulations
- •- A history of clinically significant ECG abnormalities,
- •- Known family history or known presence of long QT syndrome or Torsades de Pointes
- •- Use of agents known to prolong the QT interval unless they can be permanently discontinued for the duration of the study
- •- 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.
- •- Women of child bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 1 week after stopping of investigational drug.
- •- History of immunodeficiency diseases, or a positive HIV (ELISA and Western blot) test result.
- •- Chronic infection with Hepatitis B (HBV) or Hepatitis C (HCV).
- •- Patients who cannot receive vaccinations against N. meningitidis, S. pneumoniae, or H. influenzae
研究者
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