An Open-label Study to Assess the Efficacy and Safety of Extended TARPEYO® (Delayed-release Budesonide Capsules) Treatment in Adult Patients With Primary IgA Nephropathy Who Have Completed 9 Months of TARPEYO® 16 mg Once Daily Treatment in Real-world Clinical Practice
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 55
- 主要终点
- Ratio of Urine Protein to Creatine Ratio (UPCR) at 6 months compared to Baseline
研究概览
简要总结
The goal of this clinical trial is to assess the efficacy and safety of extended TARPEYO® (delayed-release budesonide capsules) treatment in adult patients with primary IgA nephropathy who have completed 9 months of TARPEYO® 16 mg once daily treatment in real-world clinical practice. The main question it aims to answer is:
Is there a treatment benefit of TARPEYO® 16 mg QD extended use?
Participants will
- take part in this study for about 19 months
- Have urine tests done
- Have blood samples taken
- Have physical examinations done
详细描述
This clinical trial will investigate the efficacy and safety of TARPEYO® treatment extended for an additional 15 months in adult IgAN participants who have completed their initial, single 9-month TARPEYO® 16 mg QD commercial treatment regimen. Participants with residual proteinuria will be eligible for enrollment. The Treatment Period will consist of a 6-month Treatment Period with TARPEYO® 16 mg QD, followed by a 9-month Treatment Period with TARPEYO® 8 mg QD. This will be followed by a 3-month Follow-up Period, which includes the first 2 weeks of Tapering Period with TARPEYO® 4 mg QD.
The overall aim of the extended treatment is to improve and maintain the treatment effect with reduced proteinuria and protection of kidney function over a total of 2 years of TARPEYO® treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed IgAN with biopsy verification
- •Female or male participants ≥18 years of age
- •Completion of a single, initial 9 months of treatment with TARPEYO® 16 mg QD at the Baseline visit
- •Access to retrospective local laboratory assessment data on UPCR and serum creatinine. Available retrospective data should include at least 1 assessment timepoint within 3 months prior to the first dose of TARPEYO® commercial treatment.
- •On stable treatment with renin-angiotensin system (RAS) inhibitor therapy or sparsentan for at least 8 weeks prior to the Baseline visit. A stable dose is defined as a dose within 25% of the dose at Baseline.
- •If on current treatment with sodium-glucose cotransporter-2 (SGLT2) inhibitor, the treatment should have been stable for at least 8 weeks prior to the Baseline visit. A stable dose is defined as a dose within 25% of the dose at Baseline.
排除标准
- •Participants who have been treated with systemic immunosuppressive medications including glucocorticosteroids (GCS) other than TARPEYO® during the TARPEYO® commercial treatment period. Topical or inhalation products containing GCS or immunosuppressants are allowed.
- •Presence of other glomerulopathies (e.g., C3 glomerulopathy, diabetes nephropathy and/or hypertensive nephropathy).
- •Presence of nephrotic syndrome (i.e., proteinuria >3.5 g per day and serum albumin <3.0 g/dL, with or without edema).
- •Presence of medical condition excluding continued TARPEYO® treatment, as assessed by the Investigator.
- •On current or planned dialysis.
- •Undergone kidney transplant.
- •Poorly controlled diabetes mellitus or hypertension, as assessed by the Investigator.
- •Participants with known osteoporosis in the medium- or high-risk category according to the 2010 American College of Rheumatology recommendations.
- •Any medical or social circumstance making trial participation and/or TARPEYO® treatment unsuitable, as assessed by the Investigator.
- •Participants with clinically significant infections that put the participant at risk, at the discretion of the Investigator.
- •Participants unwilling or unable to meet the requirements of the protocol.
- •Intake of another investigational drug during trial, or during the preceding 9-monthcommercial TARPEYO® treatment period.
- •Females who are pregnant, breastfeeding, or plan to become pregnant in the trial period.
- •Participants taking potent inhibitors of cytochrome P450 (CYP) 3A4
研究组 & 干预措施
16 mg QD then 8 mg QD
6-months of TARPEYO® 16 mg QD then 9-month Treatment Period with TARPEYO® 8 mg QD and TARPEYO®4 mg QD for 2 weeks for tapering.
干预措施: TARPEYO® (Drug)
结局指标
主要结局
Ratio of Urine Protein to Creatine Ratio (UPCR) at 6 months compared to Baseline
时间窗: 6 months
The outcome is measured as UPCR (based on 24-hour urine collection) at 6 months following the first dose of TARPEYO® trial treatment compared to study Baseline. Ratio being UPCR at 6 months in g/gram divided with UPCR at Baseline in g/gram.
次要结局
- Ratio of Urine Protein to Creatine Ratio (UPCR) at 15 months compared to Baseline(15 months)
- Ratio of 24-hour urine proteinuria at 6 months compared to Baseline(6 months)
- Ratio of Urine Protein to Creatine Ratio (UPCR) at 6 months compared to prior to start of TARPEYO® commercial treatment (i.e., comparison with retrospective local laboratory data from medical records as available)(18 months)
- Ratio of Urine Protein to Creatine Ratio (UPCR) at 15 months compared to prior to start of TARPEYO® commercial treatment (i.e., comparison with retrospective local laboratory data from medical records as available)(27 months)
- Ratio of estimated glomerular filtration rate (eGFR) at 6 months compared to Baseline(6 months)
- Ratio of estimated glomerular filtration rate (eGFR) at 15 months compared to Baseline(15 months)
- Ratio of estimated glomerular filtration rate (eGFR) at 6 months compared to start of TARPEYO® commercial treatment (i.e., comparison with retrospective local laboratory data from medical records as available)(18 months)
- Ratio of estimated glomerular filtration rate (eGFR) at 15 months compared to start of TARPEYO® commercial treatment (i.e., comparison with retrospective local laboratory data from medical records as available)(27 months)
- Ratio of 24-hour urine proteinuria at 15 months compared to Baseline(15 months)
- Proportion of participants with microhematuria at 6 months(6 months)
- Proportion of participants with microhematuria at 15 months(15 months)
- To evaluate the safety (SAEs and AEs) of extended TARPEYO® treatment(19 months)