Immunoglobulin A nephropathy
Conditions
Interventions
Observation group:None
Sponsors
Shanghai Sixth People’s Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age>=18 years, regardless of gender. 2.Diagnosed with primary IgA nephropathy by renal biopsy pathology. 3.Initiated a "targeted therapy" drug for the first time within 4 weeks prior to signing the informed consent form. 4.eGFR>=30 mL/min/1.73m^2; 5.Patients (or their caregivers) are capable of understanding and independently completing data entry and follow-up interactions on the decentralized clinical trial (DCT) digital platform (e.g., a mini-program). 6.Patients fully understand the purpose and requirements of this study and voluntarily sign a paper or electronic informed consent form.
Exclusion criteria
Exclusion criteria: 1.Exclusion of secondary IgA deposition nephritis caused by other diseases, including but not limited to: Henoch-Schönlein purpura nephritis, systemic lupus erythematosus, hepatitis B-associated nephritis, cirrhotic glomerulopathy, etc. 2.Presence at baseline of any serious disease that may interfere with the evaluation of study results or threaten patient safety, including but not limited to: (1) Uncontrolled active infection; (2) Severe cardiovascular or cerebrovascular disease (e.g., decompensated heart failure, myocardial infarction within the past 3 months); (3) Malignancy (except for those who have been cured with no recurrence within 1 year), or expected survival < 12 months. 3.Women who are pregnant or breastfeeding, or those planning a pregnancy during the study follow-up period. 4.Patients whom the investigator considers unsuitable for participation in this study for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of treatment regimen combinations at initiation of etiologic therapy in real-world practice; | — |
Secondary
| Measure | Time frame |
|---|---|
| Timing of intervention (time from diagnosis to initiation, time from supportive therapy to initiation);Baseline status profile (eGFR stage, UPCR category, and Oxford MEST-C score distribution at initiation);Dose adherence (total treatment days, interruption rate due to adverse events, discontinuation rate);Evolution of combination therapy (proportion of concomitant use of etiologic therapy with supportive agents or conventional immunosuppressants and trajectory of regimen changes);Proteinuria control (proportion achieving complete remission and time to remission, duration of proteinuria remission, change in UPCR from baseline at each follow-up visit);Renal function change (trend of eGFR over time, eGFR slope/annualized decline rate);Hematuria conversion rate (proportion of patients with microscopic hematuria at baseline who achieve normalized urinary red blood cell count and maintain it for at least 3 months during follow-up);Composite renal endpoint events (sustained decline in eGFR =30% from baseline, progression to end-stage renal disease (ESRD), initiation of dialysis, or all-cause mortality); | — |
Countries
China
Contacts
Public ContactWang Niansong
Shanghai Sixth People’s Hospital
Outcome results
None listed