IgA Nephropathy Insights From Treatment Experience Among Patients Receiving Iptacopan and/or Atrasentan Using Primary Data Collection

N/ANot Yet RecruitingNCT07481084

Novartis Pharmaceuticals80 enrolled

Overview

The current prospective, non-interventional study (NIS) being conducted under the IgNITE umbrella protocol using primary data collection (PDC), aims to enhance understanding of real-world patient profiles, treatment patterns, and clinical outcomes among patients with IgAN treated with iptacopan or atrasentan in the real-world clinical care setting immediately from the time of drug launch. Furthermore, this study is planned to contribute to a global meta-analysis, to enable further analysis with greater statistical power, as well as exploration of similarities and differences of treatment use and outcomes between countries and regions. Each patient will be observed for 24 months

Study Type

OBSERVATIONAL

Enrollment

80

Conditions

IgA Nephropathy

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

Inclusion criteria 1. Biopsy confirmed diagnosis of IgAN. 2. Age ≥18 years at index date. 3. Eligible for treatment with iptacopan or atrasentan as per approved drug label and local regulations at the discretion of treating physician. 4. Able to provide written consent for participation. a. Patients who withdraw their consent will be censored on this date; all aggregated and anonymised data collected up to that date will be included in a centralised IgNITE data platform. Exclusion criteria 1. Use of investigational drugs during the study, OR within 3 months before index date, OR within 5 half-lives of investigational drug before index date, OR until the expected pharmacodynamic effect has returned to baseline, whichever is longer. 2. Simultaneous participation in any investigational trial or simultaneous participation in another Novartis-sponsored study (NIS or interventional) with iptacopan/atrasentan. 3. Known hypersensitivity or contraindications to iptacopan, atrasentan, or their excipients, as documented in the patient's medical records. 4. Presence of significant comorbidities or conditions that may impact the interpretation of the study results or the patient's ability to participate in the study at the discretion of treating physician. 5. Pregnancy or other contraindications for iptacopan and/or atrasentan 6. Insufficient medical records available for the baseline and follow-up periods.

Outcomes

Primary Outcomes

Baseline demographic

Age and sex

Time frame: Index date (date of iptacopan or atrasentan initiation)

Baseline clinical characteristics: Time of IgAN diagnosis

Time of IgAN diagnosis and biopsy that's related with the IgAN dianosis

Time frame: Index date (date of iptacopan or atrasentan initiation)

Baseline clinical characteristics: Baseline MEST-C

Scored according to the Oxford classification MEST-C criteria: * Mesangial hypercellularity (M0/M1) * Endocapillary hypercellularity (E0/E1) * Segmental glomerulo- sclerosis (S0/S1) * Tubular atrophy/interstitial fibrosis (T0/T1/T2) * Crescents (C0/C1/C2)

Time frame: Index date (date of iptacopan or atrasentan initiation)

Baseline clinical characteristics: Index Blood Pressure

Time frame: Index date (date of iptacopan or atrasentan initiation)

Baseline clinical characteristics: Index eGFR

Time frame: Index date (date of iptacopan or atrasentan initiation)

Baseline clinical characteristics: Index proteinuria

Time frame: Index date (date of iptacopan or atrasentan initiation)

Baseline clinical characteristics: Index hematuria

Time frame: Index date (date of iptacopan or atrasentan initiation)

Baseline clinical characteristics: Index serum albumin level

Time frame: Index date (date of iptacopan or atrasentan initiation)

Baseline clinical characteristics: Index creatinine level

Time frame: Index date (date of iptacopan or atrasentan initiation)

Baseline clinical characteristics: Number of participants by Index CKD stage

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)

Time frame: Index date (date of iptacopan or atrasentan initiation)

Baseline clinical characteristics: Number of participants by ESKD status

ESKD status is a binary variable, meaning with or without ESKD

Time frame: Index date (date of iptacopan or atrasentan initiation)

Baseline clinical characteristics: History of dialysis and kidney transplant

Number of participants with history of dialysis and kidney transplant

Time frame: Index date (date of iptacopan or atrasentan initiation)

Baseline clinical characteristics: Baseline use of corticosteroids or targeted Budesonide for IgAN

Time frame: Index date (date of iptacopan or atrasentan initiation)

Baseline clinical characteristics: Baseline use of ACEi, ARB and SGLT2i treatments

Time frame: Index date (date of iptacopan or atrasentan initiation)

Baseline clinical characteristics: Baseline use of ERA, APRIL / APRIL-BAFF therapies, MMF, Hydroxychloroquine, nsMRA , Immunosuppressant

Baseline use of Endothelin Receptor Antagonist (ERA), A Proliferation Inducing Ligand (APRIL) / A Proliferation Inducing Ligand-B-cell Activating Factor (APRIL-BAFF) therapies, MMF, Hydroxychloroquine, nsMRA (Finerenone), Immunosuppressant

Time frame: Index date (date of iptacopan or atrasentan initiation)

Baseline clinical characteristics: Number of participants who have participated in a clinical trial

Time frame: Index date (date of iptacopan or atrasentan initiation)

Secondary Outcomes

Number of participants by treatment sequence during baseline and follow-up period

Treatment sequence refers to longitudinal sequence of lines of treatment received across the study period. The date of treatment initiation and discontinuation will be recorded to determine the number of participants by sequence of treatment.

Time frame: up to 24-months

Proteinuria

Time frame: Up to 24-months

Proteinuria control rate

Proteinuria control rate (below 0.5g/day or 0.3g/day)

Time frame: Up to 24-months

eGFR

Time frame: Up to 24-months

Time from index date to complete remission

complete remission defined as 24h proteinuria \<0.3 g/d at various time intervals, depending on data availability (i.e. 6, 12, 18 and 24 months, etc.) until the date of treatment discontinuation (iptacopan or atrasentan), death, or loss to follow-up, whichever occurs first.

Time frame: Up to 24-months

Change in Chronic Kidney Disease (CKD) stage

Time frame: Up to 24-months

Number of patients progressing to kidney failure

Time frame: Up to 24-months

Number of patients receiving dialysis

Time frame: Up to 24-months

Number of patients progressing to of kidney transplantation

Time frame: Up to 24-months

NCT07481084 - IgA Nephropathy Insights From Treatment Experience Among Patients Receiving Iptacopan and/or Atrasentan Using Primary Data Collection | Crick | Crick