JPRN-jRCT2021210041招募中3 期
A multicenter rollover extension program (REP) to evaluate the long-term safety and tolerability of open label iptacopan in adult participants with primary IgA nephropathy who have completed study CLNP023X2203 or CLNP023A2301
Yamada Hiroyuki0 个研究点目标入组 28 人开始时间: 2021年10月12日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 28
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
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1. Signed informed consent must be obtained prior to participation. Participants should be able to communicate well with the Investigator, understand and comply with the requirements of the study.
- •2. For CLNP023X2203, participants must have completed Part 1 or Part 2 of the trial. For CLNP023A2301, participants must have completed the entire parent trial defined as the full 24 month double-blind period.
- •3. eGFR >= 20 mL/min/1.73m2
- •4. Per Investigator clinical judgement, the participant may benefit from receiving the open-label treatment of iptacopan 200 mg b.i.d.
- •5. Prior vaccination against Neisseria meningitidis, Streptococcus pneumoniae and Haemophilus influenzae infections should be up to date (i.e. any boosters required administered according to local regulations).
- •6. All participants must be on supportive care regimen of stable dose of ACEi or ARB as per KDIGO guidelines.
排除标准
- •1. Participants who screen or baseline failed in the CLNP023X2203 Part 1 or Part 2, or CLNP023A2301 studies or who prematurely withdrew from either study for any reason.
- •2. Evidence of severe urinary obstruction or difficulty in voiding; any urinary tract disorder other than IgAN at screening and before dosing with iptacopan.
- •3. Current (within 4 weeks prior to study treatment administration in the REP) acute kidney injury (AKI) defined by AKIN criteria.
- •4. Presence of Rapidly Progressive Glomerulonephritis (RPGN) as defined by 50% decline in eGFR within the last 3 months.
- •5. Participants treated with immunosuppressive or other immunmodulatory agents and/or
- •systemic corticosteroids exposure (>7.5 mg/d prednisone/prednisolone equivalent) within 5 half-lives of respective medication or 90 days prior to first study drug administration, whichever is shorter.
- •6. Use of other investigational drugs at the time of enrollment, or within 5 halflives of enrollment or within 30 days whichever is longer.
- •7. All transplanted participants (any solid organ, or bone marrow transplantation).
- •8. History of recurrent invasive infections caused by encapsulated organisms, such as meningococcus, pneumococcus, and H. influenzae.
- •9. Major concurrent comorbidities including but not limited to severe uncontrolled hypertension, other chronic kidney disease (with or without kidney failure), advanced cardiac disease (e.g., NYHA class IV), severe pulmonary disease (e.g., severe pulmonary hypertension (WHO class IV), or hepatic disease (e.g. active hepatitis) that in the opinion of the Investigator precludes participant's participation in the study.
研究者
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