CTRI/2024/05/066893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).
Novartis Healthcare Pvt Ltd6 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2024年5月17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
- 试验地点
- 6
- 主要终点
- What is the treatment effect of iptacopan versus placebo on reduction of protein in urine in participants with IC-MPGN
研究概览
简要总结
The purpose of this Phase III study is to evaluate the efficacy and safety of iptacopan compared to placebo (and standard of care) in participants (adults and adolescents aged 12-17 years) with idiopathic (primary) IC-MPGN in native kidneys.
The study duration will be up to 480 days, including the pre-treatment (screening) and post-treatment safety follow-up periods.
The treatment duration will be up to 360 days.
There will be up to four visits during the 90-day screening period/Run-in period, five visits in the first 6-month treatment period and three visits in the second 6-month treatment period
After the end of study, participants will have the option to transition to an extension study and continue iptacopan treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 12.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosis of idiopathic IC-MPGN as confirmed by kidney 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 in an adult participant, this must be obtained at screening (performed and assessed locally for adults only). Prior to randomization, all participants must have been on a maximally recommended or tolerated dose of an ACEI or ARB for at least 90 days (or as according to local guidelines). The doses of other drugs administered to reduce proteinuria and control the disease including mycophenolic acids (MPAs.
- •mycophenolate mofetil or mycophenolate sodium), corticosteroids, SGLT2 inhibitors and mineralocorticoid receptor antagonists should be stable for at least 90 days prior to randomization UPCR ≥ 1.0 g/g (≥ 113 mg/mmol) sampled from the first morning void urine sample at Day -75 and Day -15 Estimated GFR (using the chronic kidney disease [CKD]-EPI formula for adult participants and modified Schwartz formula for adolescents aged 12 to 17 years) or measured GFR ≥ 30 ml/min/1.73m2 at screening and Day -
- •Mandatory vaccination against Neisseria meningitidis and Streptococcus pneumoniae infection prior to the start of study treatment. If the participant 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 the study treatment has to start earlier than 2 weeks post vaccination, prophylactic antibiotic treatment should be initiated in accordance with local standard of care. •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 the study treatment has to start earlier than 2 weeks post vaccination, prophylactic antibiotic treatment should be initiated in accordance with local standard of care.
排除标准
- •Participants who have undergone cell or solid organ transplantation, including kidney transplantation.
- •Participants 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 chronic infections, including Hepatitis C virus (HCV) including HCV-associated mixed cryoglobulinemia, hepatitis B virus (HBV); Bacterial-endocarditis, infected ventriculo-atrial shunt, visceral abscesses, leprosy, meningococcal meningitis; chronic bacterial infections Protozoa/other infections- malaria, schistosomiasis, mycoplasma, leishmaniasis, filariasis, histroplasmosis Renal deposition of immune complexes as a result of a systemic autoimmune disease: Systemic lupus erythematosus (SLE) Sjögren syndrome Rheumatoid arthritis Mixed connective tissue disease Deposition of monoclonal immunglobulins 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 Rapidly progressive crescentic glomerulonephritis defined as a 50% decline in the eGFR within 3 months with kidney biopsy findings of glomerular crescent formation seen in at least 50% of glomeruli on the most recent biopsy.
- •Kidney biopsy showing interstitial fibrosis/tubular atrophy (IF/TA) of more than 50%.
- •Participants with an active systemic bacterial, viral or fungal infection within 14 days prior to study treatment administration or 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., Neisseria meningitidis and Streptococcus pneumoniae.
- •The use of inhibitors of complement factors (e.g., Factor B, Factor D, complement 3 (C3) inhibitors, anti-Complement 5 (C5) antibodies, C5a receptor antagonists) within 6 months prior to the Screening visit.
- •The use of immunosuppressants (except MPAs), cyclophosphamide or systemic corticosteroids at a dose >7.5 mg/day (or equivalent for a similar corticosteroid medication) within 90 days of study drug administration.
- •The use of MPAs is not permitted within 90 days prior to randomization in India, as per the local health authority requirement.
- •Acute post-infectious glomerulonephritis at screening, based upon the opinion of the investigator.
结局指标
主要结局
What is the treatment effect of iptacopan versus placebo on reduction of protein in urine in participants with IC-MPGN
时间窗: Lower levels of protein in urine measured by UPCR (Urine Protein Creatine Ratio) after 6 months of iptacopan treatment.
次要结局
- To demonstrate the superiority of iptacopan compared to placebo in improvement of patient-reported fatigue.(Number of adverse events & any discontinuations from study due to these adverse events during the first 6 months of treatment.)
- To demonstrate the superiority of iptacopan vs. placebo in improving estimated Glomerular Filtration Rate (eGFR(Change in Estimated Glomerular Filtration Rate (eGFR) measurement after 6 months of iptacopan treatment)
- To demonstrate the superiority of iptacopan vs. placebo in the proportion of participant who achieved a composite renal endpoint(Change from day 1 to 6 months in the reported fatigue levels (Functional Assessment of Chronic Illness Therapy-Fatigue [FACIT-Fatigue] score))
- To evaluate the safety & tolerability of iptacopan compared to placebo during the 6-month double-blind period.(In adolescents, the number of adverse events relating to heart function (e.g., Blood pressure & heart rate) throughout the treatment period.)
研究者
研究点 (6)
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