JPRN-jRCT2031230365招募中3 期
A multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of iptacopan (LNP023) in idiopathic immune complex mediated membranoproliferative glomerulonephritis (IC-MPGN)
Hirano Takamitsu0 个研究点目标入组 68 人开始时间: 2023年9月27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
- 68
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
- >= 12age old 至 <= 60age old（—）
- 性别
- All
入选标准
- •1. Male and female participants age >= 12 and =< 60 years at screening.
- •2. Diagnosis of IC-MPGN as confirmed by renal biopsy within 12 months prior to enrollment in
- •adults and within 3 years in adolescents.
- •3. 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 acid, corticosteroids and mineralocorticoid receptor antagonists should be stable for at least 90 days prior to randomization.
- •4. UPCR >= 1.0 g/g sampled from the first morning void urine sample at Day -75 and Day -15.
- •5. Estimated GFR (using the CKD-EPI formula) or measured GFR >= 30 ml/min/1.73m2 at screening and Day -15.
- •6. Vaccination against Neisseria meningitidis infection prior to the start of study treatment. Vaccination against Streptococcus pneumoniae and Haemophilus influenzae infections should be given, if available and according to local regulations.
排除标准
- •1. Participants who have received any cell or organ transplantation, including a kidney transplantation.
- •2.Patients diagnosed with secondary IC-MPGN including but not limited to any of the following conditions:
- •- Deposition of antigen-antibody immune complexes as a result of any infection, including
- •Viral- hepatitis C including HCV-associated mixed cryoglobulinemia, hepatitis B;
- •Bacterial-endocarditis, infected ventriculo-atrial shunt, visceral abscesses, leprosy, meningococcal meningitis; chronic bacterial infections
- •Protozoa/other infections- malaria, schistosomiasis, mycoplasma, leishmaniasis, filariasis, histroplasmosis)
- •- Deposition of immune complexes as a result of an autoimmune disease:
- •Sjogren syndrome
- •Rheumatoid arthritis
- •Mixed connective tissue disease, etc
- •- Disposition of monoclonal Ig because of a monoclonal gammopathy due to plasma cell or B cell disorders. Monoclonal gammopathy of undetermined significance (MGUS) confirmed by the measurement of serum free light chains or other investigation as per local standard of care.
- •- Fibrillary glomerulonephritis
- •3. 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.
- •4. Renal biopsy showing interstitial fibrosis/tubular atrophy (IF/TA) of more than 50%.
- •5. Participants with an active systemic bacterial, viral or fungal infection within 14 days prior to study treatment administration
- •6. The presence of fever >= 38 degree celsius (100.4 degree farenheit) within 7 days prior to study treatment administration.
- •7. A history of recurrent invasive infections caused by encapsulated organisms, e.g., N. meningitidis and S. pneumoniae.
- •8. The use of inhibitors of complement factors (e.g., Factor B, Factor D, C3 inhibitors, anti C5 antibodies, C5a receptor antagonists) within 6 months prior to the Screening visit.
- •9. 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.
研究者
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