IgA Nephropathy
Conditions
Keywords
China IgNITE, Iptacopan, atrasentan
Brief summary
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
Interventions
None listed
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Baseline demographic | Index date (date of iptacopan or atrasentan initiation) | Age and sex |
| Baseline clinical characteristics: Time of IgAN diagnosis | Index date (date of iptacopan or atrasentan initiation) | Time of IgAN diagnosis and biopsy that's related with the IgAN dianosis |
| Baseline clinical characteristics: Baseline MEST-C | Index date (date of iptacopan or atrasentan initiation) | 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) |
| Baseline clinical characteristics: Index Blood Pressure | Index date (date of iptacopan or atrasentan initiation) | — |
| Baseline clinical characteristics: Index eGFR | Index date (date of iptacopan or atrasentan initiation) | — |
| Baseline clinical characteristics: Index proteinuria | Index date (date of iptacopan or atrasentan initiation) | — |
| Baseline clinical characteristics: Index hematuria | Index date (date of iptacopan or atrasentan initiation) | — |
| Baseline clinical characteristics: Index serum albumin level | Index date (date of iptacopan or atrasentan initiation) | — |
| Baseline clinical characteristics: Index creatinine level | Index date (date of iptacopan or atrasentan initiation) | — |
| Baseline clinical characteristics: Number of participants by Index CKD stage | Index date (date of iptacopan or atrasentan initiation) | 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) |
| Baseline clinical characteristics: Number of participants by ESKD status | Index date (date of iptacopan or atrasentan initiation) | ESKD status is a binary variable, meaning with or without ESKD |
| Baseline clinical characteristics: History of dialysis and kidney transplant | Index date (date of iptacopan or atrasentan initiation) | Number of participants with history of dialysis and kidney transplant |
| Baseline clinical characteristics: Baseline use of corticosteroids or targeted Budesonide for IgAN | Index date (date of iptacopan or atrasentan initiation) | — |
| Baseline clinical characteristics: Baseline use of ACEi, ARB and SGLT2i treatments | Index date (date of iptacopan or atrasentan initiation) | — |
| Baseline clinical characteristics: Baseline use of ERA, APRIL / APRIL-BAFF therapies, MMF, Hydroxychloroquine, nsMRA , Immunosuppressant | Index date (date of iptacopan or atrasentan initiation) | 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 |
| Baseline clinical characteristics: Number of participants who have participated in a clinical trial | Index date (date of iptacopan or atrasentan initiation) | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants by treatment sequence during baseline and follow-up period | up to 24-months | 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. |
| Proteinuria | Up to 24-months | — |
| Proteinuria control rate | Up to 24-months | Proteinuria control rate (below 0.5g/day or 0.3g/day) |
| eGFR | Up to 24-months | — |
| Time from index date to complete remission | Up to 24-months | 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. |
| Change in Chronic Kidney Disease (CKD) stage | Up to 24-months | — |
| Number of patients progressing to kidney failure | Up to 24-months | — |
| Number of patients receiving dialysis | Up to 24-months | — |
| Number of patients progressing to of kidney transplantation | Up to 24-months | — |
Contacts
CONTACTNovartis Pharmaceuticals
STUDY_DIRECTORNovartis Pharmaceuticals
Novartis Pharmaceuticals
Outcome results
None listed