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

NCT07757048 | Completed

• 1 other identifier: CLNP023AUS11
• Study Type: observational
• Target: 6,286
• Locations: 1 country
• Sites: 1

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.

Conditions

IGA Nephropathy

Keywords

IgA Nephropathy

Outcome Measures

Primary Outcomes (9)

• 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

  Drug classes of interest include: * RAASi * Corticosteroids/glucocorticoids/MMF * SGLT2i * Targeted release budesonide * Sparsentan * Atrasentan * Iptacopan * Sibeprenlimab

  365 days

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

  Drug classes of interest include: * RAASi * Corticosteroids/glucocorticoids/MMF * SGLT2i * Targeted release budesonide * Sparsentan * Atrasentan * Iptacopan * Sibeprenlimab

  365 days

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

  Drug classes of interest include: * RAASi * Corticosteroids/glucocorticoids/MMF * SGLT2i * Targeted release budesonide * Sparsentan * Atrasentan * Iptacopan * Sibeprenlimab

  365 days

• Duration of Each Line of Therapy (LOT)

  365 days

• For Each LOT, Number of Fills of Each Drug Class

  365 days

• 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

  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.

  365 days

Secondary Outcomes (30)

• 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

• eGFR

  Baseline

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with biopsy-confirmed IgAN in the US.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis

East Hanover, New Jersey, 07936, United States

Location

MeSH Terms

Conditions

Glomerulonephritis, IGA

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 11, 2026
• Study Start: March 12, 2026
• Primary Completion: July 1, 2026
• Study Completion: July 1, 2026
• Last Updated: August 11, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)