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Completed

NCT Number: NCT07757048

A Study of Treatment Patterns and Real-World Outcomes in IgA Nephropathy Patients in the United States

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.

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Key information

Conditions

IgA Nephropathy Autoimmune Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glomerulonephritis Glomerulonephritis, IGA Immune System Diseases Kidney Diseases Male Urogenital Diseases Nephritis Urogenital Diseases Urologic Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis

East Hanover, New Jersey, 07936, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Proportion of Patients Treated With any Therapy at any Time During the Study Period

    Time frame: 365 days

  2. Among Patients that Received Treatment, Proportion of Patients Who Received any of the Drug Classes of Interest at any Time During the Study Period

    Time frame: 365 days

    Drug classes of interest include:

    • RAASi
    • Corticosteroids/glucocorticoids/MMF
    • SGLT2i
    • Targeted release budesonide
    • Sparsentan
    • Atrasentan
    • Iptacopan
    • Sibeprenlimab

  3. Among Patients that Received Treatment, Number of Fills of the Drugs in Drug Classes of Interest

    Time frame: 365 days

    Drug classes of interest include:

    • RAASi
    • Corticosteroids/glucocorticoids/MMF
    • SGLT2i
    • Targeted release budesonide
    • Sparsentan
    • Atrasentan
    • Iptacopan
    • Sibeprenlimab

  4. Among Patients that Received Treatment, Duration of Treatment With Drugs in Drug Classes of Interest

    Time frame: 365 days

    Drug classes of interest include:

    • RAASi
    • Corticosteroids/glucocorticoids/MMF
    • SGLT2i
    • Targeted release budesonide
    • Sparsentan
    • Atrasentan
    • Iptacopan
    • Sibeprenlimab

  5. Duration of Each Line of Therapy (LOT)

    Time frame: 365 days

  6. For Each LOT, Number of Fills of Each Drug Class

    Time frame: 365 days

  7. For Each LOT, Percentage of Patients that Discontinue First-line (1L), Second-line (2L), and Third-line (3L) of Therapy

    Time frame: 365 days

  8. Among Patients Who Discontinue 1L, 2L, 3L Therapy, Time to Treatment Discontinuation

    Time frame: 365 days

  9. Among Patients that Received Treatment, Proportion of Patients by Treatment Sequence

    Time frame: 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.

Secondary outcomes

  1. Proportion of Patients by Demographics, Clinical, and Laboratory Characteristics

    Time frame: 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)

  2. Age at Index

    Time frame: Baseline

  3. Charlson Comorbidity Index (CCI) Score

    Time frame: 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).

  4. Proportion of Patients by Chronic Kidney Disease (CKD) Stage

    Time frame: 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)

  5. eGFR

    Time frame: Baseline

  6. eGFR Slope

    Time frame: Baseline

  7. Proteinuria

    Time frame: Baseline

    Proteinuria assessed using UPCR.

  8. Mesangial Hypercellularity, Endocapillary Hypercellularity, Segmental Glomerulosclerosis, Tubular Atrophy/Interstitial Fibrosis, Crescents (MEST-C) Score

    Time frame: 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).

    • Mesangial hypercellularity (M)
    • M0 (present in ≤50% of glomeruli)
    • M1 (present in >50% of glomeruli)
    • Endocapillary hypercellularity (E)
    • E0 (Absent)
    • E1 (Present)
    • Segmental glomerulosclerosis (S)
    • S0 (Absent)
    • S1 (Present)
    • Tubular atrophy/interstitial fibrosis (T)
    • T0 (0-25% of cortical area)
    • T1 (26-50% of cortical area)
    • T2 (>50% of cortical area)
    • Cellular crescents (C)
    • C0 (No crescents)
    • C1 (present in <25% of glomeruli)
    • C2 (present in ≥25% of glomeruli)

  9. Proportion of Patients Achieving Proteinuria <0.3 g/d

    Time frame: 365 days

  10. Proportion of Patients Achieving Proteinuria <0.5g/d

    Time frame: 365 days

  11. Proportion of Patients Treated With any Therapy at any Time During the Study Period, Categorized by Disease Management Goal Status

    Time frame: 365 days

    Disease management goal status is a binary variable, meaning patients achieved or did not achieve disease management.

  12. 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

    Time frame: 365 days

  13. Among Patients that Received Treatment, Duration of Treatment With Drugs in Each Drug Class of Interest, Categorized by Disease Management Goal Status

    Time frame: 365 days

  14. Among Patients that Received Treatment, Number of LOTs Received, Categorized by Disease Management Goal Status

    Time frame: 365 days

  15. Among Patients that Received Treatment, Proportion of Patients by Most Common Treatment Sequences, Categorized by Disease Management Goal Status

    Time frame: 365 days

  16. Number of Steroid-related Adverse Events (AEs) per Patient per Year (PPPY)

    Time frame: 365 days

  17. Proportion of Patients with ≥1 Steroid-related AE

    Time frame: 365 days

  18. Proportion of Patients With ≥1 Steroid-related AE-related Outpatient, Inpatient, and Emergency Department Visit

    Time frame: 365 days

  19. Number of Steroid-related AE-related Outpatient, Inpatient, and Emergency Department Visits

    Time frame: 365 days

  20. Proportion of Patients With ≥1 ARB-related AE

    Time frame: 365 days

  21. Number of ARB-related AEs PPPY

    Time frame: 365 days

  22. Proportion of Patients With ≥1 ARB-related AE-related Outpatient, Inpatient, and Emergency Department Visit

    Time frame: 365 days

  23. Number of ARB-related AE-related Outpatient, Inpatient, and Emergency Department Visits

    Time frame: 365 days

  24. Among Patients Treated With RAASi Therapy Who had Elevated and Non-elevated Proteinuria, Proportion of Patients by Demographics and Clinical Characteristics

    Time frame: Baseline

    Demographics and clinical characteristics include:

    • Age group
    • Sex
    • Race
    • Ethnicity
    • Insurance type
    • Comorbidities

  25. Among Patients Treated With RAASi Therapy Who had Elevated and Non-elevated Proteinuria, Age at Index

    Time frame: Baseline

  26. Among Patients Treated With RAASi Therapy Who had Elevated and Non-elevated Proteinuria, CCI Score

    Time frame: Baseline

  27. Proportion of Patients With Elevated Proteinuria Who Moved onto a Subsequent LOT Following the RAASi Containing LOT

    Time frame: 182 days

    Proportion of patients with treatment escalation.

  28. Proportion of Patients Who Escalated to Another Drug, by Class of Drug

    Time frame: 182 days

    Drug classes include SGLT2is, immunosuppressants (corticosteroids and MMF), and IgAN branded therapy.

  29. Proportion of Patients by Each Post-escalation Treatment Sequence

    Time frame: 182 days

  30. Time to Treatment Escalation for Patients With Elevated Proteinuria After Receiving Treatment With RAASi Therapy

    Time frame: 182 days

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

Current Treatment Patterns and Real-World Outcomes of Patients With IgA Nephropathy in the United States

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 11, 2026
Registry last updated
Aug 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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