IGA Nephropathy
Conditions
Keywords
IgA Nephropathy
Brief summary
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.
Interventions
None listed
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| For Each LOT, Percentage of Patients that Discontinue First-line (1L), Second-line (2L), and Third-line (3L) of Therapy | 365 days | — |
| Among Patients Who Discontinue 1L, 2L, 3L Therapy, Time to Treatment Discontinuation | 365 days | — |
| Among Patients that Received Treatment, Proportion of Patients by Treatment Sequence | 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. |
| Proportion of Patients Treated With any Therapy at any Time During the Study Period | 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 | 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 | 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 | 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) | 365 days | — |
| For Each LOT, Number of Fills of Each Drug Class | 365 days | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proteinuria | Baseline | Proteinuria assessed using UPCR. |
| Mesangial Hypercellularity, Endocapillary Hypercellularity, Segmental Glomerulosclerosis, Tubular Atrophy/Interstitial Fibrosis, Crescents (MEST-C) Score | Baseline | MEST-C score is the histopathologic classification system used in IgAN kidney biopsies to describe key lesions associated with disease progression. It is part of the Oxford Classification and is recommended as part of IgAN assessment. It includes five components. All five components are scored by categorical values as listed below. A higher score indicates involvement or a relatively greater degree of involvement (i.e., more severe pathology). 1. Mesangial hypercellularity (M) * M0 (present in ≤50% of glomeruli) * M1 (present in \>50% of glomeruli) 2. Endocapillary hypercellularity (E) * E0 (Absent) * E1 (Present) 3. Segmental glomerulosclerosis (S) * S0 (Absent) * S1 (Present) 4. Tubular atrophy/interstitial fibrosis (T) * T0 (0-25% of cortical area) * T1 (26-50% of cortical area) * T2 (\>50% of cortical area) 5. Cellular crescents (C) * C0 (No crescents) * C1 (present in \<25% of glomeruli) * C2 (present in ≥25% of glomeruli) |
| 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 | Disease management goal status is a binary variable, meaning patients achieved or did not achieve disease management. |
| 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 | Demographics and clinical characteristics include: * Age group * Sex * Race * Ethnicity * Insurance type * Comorbidities |
| 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 with treatment escalation. |
| Proportion of Patients Who Escalated to Another Drug, by Class of Drug | 182 days | Drug classes include SGLT2is, immunosuppressants (corticosteroids and MMF), and IgAN branded therapy. |
| 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 | — |
| Proportion of Patients by Demographics, Clinical, and Laboratory Characteristics | Baseline | Demographics, clinical, and laboratory characteristics include: * Age group * Sex * Race * Ethnicity * Insurance type * Charlson Comorbidity Index (CCI) group (0, 1, 2, 3+) * Comorbidities * Proteinuria category * Hematuria (yes/no) * Glomerular inflammation (yes/no) |
| Age at Index | Baseline | — |
| Charlson Comorbidity Index (CCI) Score | Baseline | CCI is a weighted index that takes into account both the number and the seriousness of comorbid diseases. It predicts the ten-year mortality for a patient who may have a range of comorbid conditions. CCI can be categorized as low (0-1) and high (≥2). |
| Proportion of Patients by Chronic Kidney Disease (CKD) Stage | Baseline | CKD stages: * Stage 1: Normal or minimal kidney damage with normal GFR (eGFR ≥90 mL/min/1.73m²) * Stage 2: Mild decrease in GFR (eGFR 60-89 mL/min/1.73m²) * Stage 3a: Mild to moderate decrease in GFR (eGFR 45-59 mL/min/1.73m²) * Stage 3b: Moderate to severe decrease in GFR (eGFR 30-44 mL/min/1.73m²) * Stage 4: Severe decrease in GFR (eGFR 15-29 mL/min/1.73m²) * Stage 5: Kidney failure (eGFR \<15 mL/min/1.73m²) |
| eGFR | Baseline | — |
| eGFR Slope | Baseline | — |
Countries
United States
Contacts
STUDY_DIRECTORNovartis Pharmaceuticals
Novartis Pharmaceuticals
Outcome results
None listed