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

CompletedN/A

Sponsor: Novartis Pharmaceuticals

Conditions: IGA Nephropathy

Countries: 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.

Eligibility overview

Sex: ALL

Age: 18 Years to 100 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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.

Locations (1)

East Hanover, New Jersey, United States