EUCTR2020-004589-21-SK进行中（未招募）1 期
A multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of iptacopan (LNP023) in complement 3 glomerulopathy
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 83
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
- 性别
- All
入选标准
- •- Male and female participants age = 18 and = 60 years (adult cohort) or age = 12 and = 17 years (adolescent cohort) at screening.
- •- Diagnosis of C3G as confirmed by renal biopsy within 12 months prior to enrollment in adults and within 3 years of enrollment in adolescents (a biopsy report, review and confirmation by the Investigator is required). If such a biopsy is not available, confirmation may be obtained using tissue from the Day -45 biopsy (adults only) for local assessment (tissue may be processed, evaluated, and reported by Arkana Laboratories but eligibility is determined by the Investigator).
- •- Prior to randomization, all participants must have been on a maximally recommended or tolerated dose of an angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) for at least 90 days. The doses of other antiproteinuric medications including mycophenolic acids, corticosteroids, and mineralocorticoid receptor antagonists should be stable for at least 90 days prior to randomization.
- •- Reduced serum C3 (defined as less than 0.85 x lower limit of the central laboratory normal range) at Screening.
- •- UPCR = 1.0 g/g sampled from the first morning void urine sample at Day -75 and Day -15.
- •- Estimated GFR (using the CKD-EPI formula for adults and modified
- •Schwartz formula for adolescents) or measured GFR = 30
- •ml/min/1.73m2 at Screening and Day -15.
- •- Mandatory vaccination against Neisseria meningitidis and
- •Streptococcus pneumoniae infection prior to the start of study
- •treatment. If the patient has not been previously vaccinated, or if a
- •booster is required, the vaccine should be given according to local
- •regulations at least 2 weeks prior to the first administration of study
- •treatment. If study treatment has to start earlier than 2 weeks post
- •vaccination, prophylactic antibiotic treatment should be initiated.
- •- If not previously vaccinated, or if a booster is required, vaccination
- •against Haemophilus influenzae infections should be given, if available and according to local regulations, at least 2 weeks prior to the first study treatment administration. If study treatment has to start earlier than 2 weeks post vaccination, prophylactic antibiotic treatment should be initiated.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 15
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 68
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Participants who have received any cell or organ transplantation, including kidney transplantation.
- •- Rapidly progressive crescentic glomerulonephritis defined as a 50% decline in the eGFR within 3 months with renal biopsy findings of glomerular crescent formation seen in at least 50% of glomeruli.
- •- Renal biopsy showing interstitial fibrosis/tubular atrophy (IF/TA) of more than 50%.
- •- Monoclonal gammopathy of undetermined significance (MGUS) confirmed by the measurement of serum free light chains or other investigation as per local standard of care.
- •- Participants with an active systemic bacterial, viral or fungal infection within 14 days prior to study treatment administration.
- •- The presence of fever = 38°C (100.4°F) within 7 days prior to study treatment administration.
- •- A history of recurrent invasive infections caused by encapsulated organisms, e.g., meningococcus or pneumococcus
- •- The use of inhibitors of complement factors (e.g., Factor B, Factor D, C3 inhibitors, anti Complement 5 (C5) antibodies, C5a receptor antagonists) within 6 months prior to the Screening visit.
- •- The use of immunosuppressants (except mycophenolic acids),
- •cyclophosphamide or systemic corticosteroids at a dose >7.5 mg/day (or equivalent for a similar medication) within 90 days of study drug administration.
- •The use of mycophenolic acids is not permitted within 90 days prior to randomization in India.
- •- Acute post-infectious glomerulonephritis at screening based upon the opinion of the investigator
研究者
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