Current Treatment Patterns and Real-World Outcomes of Patients With IgA Nephropathy in the United States
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6,286
- 试验地点
- 1
- 主要终点
- Among Patients Who Discontinue 1L, 2L, 3L Therapy, Time to Treatment Discontinuation
研究概览
简要总结
The aim of this study was to characterize real-world treatment patterns, including therapy sequences, escalation, and duration, and treatment outcomes in IgA nephropathy (IgAN) patients in the United States (US). The study used data which has detailed information on renal biopsy and laboratory data, linked with medical and pharmacy claims.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •IgAN Cohort:
- •Renal biopsy confirming IgAN during the patient identification period.
- •Age ≥18 at index. The index date was the date of first claim or biopsy.
- •≥182 days of continuous enrollment in medical and pharmacy claims before index date.
- •≥365 days of continuous enrollment in medical and pharmacy claims following (and including) index date.
- •Treatment Escalation Cohort:
- •Renal biopsy confirming IgAN during the patient identification period.
- •Age ≥18 at index.
- •≥182 days of continuous enrollment in medical and pharmacy claims before index date.
- •≥182 days of continuous enrollment in medical and pharmacy claims following (and including) index date.
- •Evidence of treatment with a renin-angiotensin-aldosterone system inhibitor (RAASi) for > 3 months following IgAN diagnosis date.
- •≥1 urine protein creatinine ratio (UPCR) lab measurement following the index date.
排除标准
- •IgAN Cohort:
- •Presence of systemic lupus erythematosus (SLE), lupus nephritis (LN), IgA vasculitis (IgAV), chronic liver disease, and Minimal Change Disease (MCD) with IgA deposition at any time during the study period.
- •Treatment Escalation Cohort:
- •Presence of SLE, LN, IgAV, chronic liver disease, and MCD with IgA deposition at any time during the study period.
- •Any evidence of kidney failure as defined by estimated glomerular filtration rate (eGFR) <15 ml/min/1.73 m², International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) codes for chronic kidney disease (CKD) stage 5, Current Procedural Terminology (CPT) codes for kidney transplant or dialysis prior to RAASi initiation.
- •Received any corticosteroids/mycophenolate mofetil (MMF), sodium-glucose co-transporter 2 inhibitor (SGLT2i), or IgAN branded therapies prior to the end of the 90 days of RAASi treatment.
研究组 & 干预措施
IgAN Cohort
Adult patients with biopsy-confirmed IgAN.
Treatment Escalation Cohort
A subgroup of the IgAN Cohort. Patients treated with RAASi who progressed beyond supportive care (3-month course of angiotensin-converting enzyme inhibitor/angiotensin receptor blocker (ACEi/ARB) therapy) and were candidates for additional therapy following insufficient disease management measured by elevated proteinuria.
结局指标
主要结局
Among Patients Who Discontinue 1L, 2L, 3L Therapy, Time to Treatment Discontinuation
时间窗: 365 days
For Each LOT, Number of Fills of Each Drug Class
时间窗: 365 days
For Each LOT, Percentage of Patients that Discontinue First-line (1L), Second-line (2L), and Third-line (3L) of Therapy
时间窗: 365 days
Proportion of Patients Treated With any Therapy at any Time During the Study Period
时间窗: 365 days
Among Patients that Received Treatment, Proportion of Patients Who Received any of the Drug Classes of Interest at any Time During the Study Period
时间窗: 365 days
Drug classes of interest include: * RAASi * Corticosteroids/glucocorticoids/MMF * SGLT2i * Targeted release budesonide * Sparsentan * Atrasentan * Iptacopan * Sibeprenlimab
Among Patients that Received Treatment, Number of Fills of the Drugs in Drug Classes of Interest
时间窗: 365 days
Drug classes of interest include: * RAASi * Corticosteroids/glucocorticoids/MMF * SGLT2i * Targeted release budesonide * Sparsentan * Atrasentan * Iptacopan * Sibeprenlimab
Among Patients that Received Treatment, Duration of Treatment With Drugs in Drug Classes of Interest
时间窗: 365 days
Drug classes of interest include: * RAASi * Corticosteroids/glucocorticoids/MMF * SGLT2i * Targeted release budesonide * Sparsentan * Atrasentan * Iptacopan * Sibeprenlimab
Duration of Each Line of Therapy (LOT)
时间窗: 365 days
Among Patients that Received Treatment, Proportion of Patients by Treatment Sequence
时间窗: 365 days
Treatment sequence refers to longitudinal sequence of LOTs received across the follow-up period. The date of treatment initiation and line end date was recorded to determine the number of patients by sequence of treatment. Line end date was defined as the date of the earliest of censoring or treatment discontinuation. Patients were censored at the earliest date of death, disenrollment, or end of the study period.
次要结局
- eGFR(Baseline)
- eGFR Slope(Baseline)
- Proportion of Patients by Demographics, Clinical, and Laboratory Characteristics(Baseline)
- Age at Index(Baseline)
- Charlson Comorbidity Index (CCI) Score(Baseline)
- Proportion of Patients by Chronic Kidney Disease (CKD) Stage(Baseline)
- Proteinuria(Baseline)
- Mesangial Hypercellularity, Endocapillary Hypercellularity, Segmental Glomerulosclerosis, Tubular Atrophy/Interstitial Fibrosis, Crescents (MEST-C) Score(Baseline)
- Proportion of Patients Achieving Proteinuria <0.3 g/d(365 days)
- Proportion of Patients Achieving Proteinuria <0.5g/d(365 days)
- Proportion of Patients Treated With any Therapy at any Time During the Study Period, Categorized by Disease Management Goal Status(365 days)
- Among Patients that Received Treatment, Proportion of Patients Who Received any of the Drug Classes of Interest at any Time During the Study Period, Categorized by Disease Management Goal Status(365 days)
- Among Patients that Received Treatment, Duration of Treatment With Drugs in Each Drug Class of Interest, Categorized by Disease Management Goal Status(365 days)
- Among Patients that Received Treatment, Number of LOTs Received, Categorized by Disease Management Goal Status(365 days)
- Among Patients that Received Treatment, Proportion of Patients by Most Common Treatment Sequences, Categorized by Disease Management Goal Status(365 days)
- Number of Steroid-related Adverse Events (AEs) per Patient per Year (PPPY)(365 days)
- Proportion of Patients with ≥1 Steroid-related AE(365 days)
- Proportion of Patients With ≥1 Steroid-related AE-related Outpatient, Inpatient, and Emergency Department Visit(365 days)
- Number of Steroid-related AE-related Outpatient, Inpatient, and Emergency Department Visits(365 days)
- Proportion of Patients With ≥1 ARB-related AE(365 days)
- Number of ARB-related AEs PPPY(365 days)
- Proportion of Patients With ≥1 ARB-related AE-related Outpatient, Inpatient, and Emergency Department Visit(365 days)
- Number of ARB-related AE-related Outpatient, Inpatient, and Emergency Department Visits(365 days)
- Among Patients Treated With RAASi Therapy Who had Elevated and Non-elevated Proteinuria, Proportion of Patients by Demographics and Clinical Characteristics(Baseline)
- Among Patients Treated With RAASi Therapy Who had Elevated and Non-elevated Proteinuria, Age at Index(Baseline)
- Among Patients Treated With RAASi Therapy Who had Elevated and Non-elevated Proteinuria, CCI Score(Baseline)
- Proportion of Patients With Elevated Proteinuria Who Moved onto a Subsequent LOT Following the RAASi Containing LOT(182 days)
- Proportion of Patients Who Escalated to Another Drug, by Class of Drug(182 days)
- Proportion of Patients by Each Post-escalation Treatment Sequence(182 days)
- Time to Treatment Escalation for Patients With Elevated Proteinuria After Receiving Treatment With RAASi Therapy(182 days)