China IgNITE - Umbrella Protocol: IgA Nephropathy Insights From Treatment Experience Among Patients Receiving Iptacopan and/or Atrasentan Using Primary Data Collection
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 主要终点
- Baseline demographic
研究概览
简要总结
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Biopsy confirmed diagnosis of IgAN.
- •Age ≥18 years at index date.
- •Eligible for treatment with iptacopan or atrasentan as per approved drug label and local regulations at the discretion of treating physician.
- •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.
排除标准
- •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.
- •Simultaneous participation in any investigational trial or simultaneous participation in another Novartis-sponsored study (NIS or interventional) with iptacopan/atrasentan.
- •Known hypersensitivity or contraindications to iptacopan, atrasentan, or their excipients, as documented in the patient's medical records.
- •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.
- •Pregnancy or other contraindications for iptacopan and/or atrasentan
- •Insufficient medical records available for the baseline and follow-up periods.
结局指标
主要结局
Baseline demographic
时间窗: Index date (date of iptacopan or atrasentan initiation)
Age and sex
Baseline clinical characteristics: Time of IgAN diagnosis
时间窗: 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
时间窗: 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
时间窗: Index date (date of iptacopan or atrasentan initiation)
Baseline clinical characteristics: Index eGFR
时间窗: Index date (date of iptacopan or atrasentan initiation)
Baseline clinical characteristics: Index proteinuria
时间窗: Index date (date of iptacopan or atrasentan initiation)
Baseline clinical characteristics: Index hematuria
时间窗: Index date (date of iptacopan or atrasentan initiation)
Baseline clinical characteristics: Index serum albumin level
时间窗: Index date (date of iptacopan or atrasentan initiation)
Baseline clinical characteristics: Index creatinine level
时间窗: Index date (date of iptacopan or atrasentan initiation)
Baseline clinical characteristics: Baseline use of ERA, APRIL / APRIL-BAFF therapies, MMF, Hydroxychloroquine, nsMRA , Immunosuppressant
时间窗: 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 by Index CKD stage
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Index date (date of iptacopan or atrasentan initiation)
Baseline clinical characteristics: Baseline use of ACEi, ARB and SGLT2i treatments
时间窗: Index date (date of iptacopan or atrasentan initiation)
Baseline clinical characteristics: Number of participants who have participated in a clinical trial
时间窗: Index date (date of iptacopan or atrasentan initiation)
次要结局
- Number of participants by treatment sequence during baseline and follow-up period(up to 24-months)
- Proteinuria(Up to 24-months)
- Proteinuria control rate(Up to 24-months)
- eGFR(Up to 24-months)
- Time from index date to complete remission(Up to 24-months)
- 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)