Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-24 @ 11:42 PM
NCT ID:
NCT07074951
Eligibility Criteria:
Inclusion Criteria:
Primary IgA-nephropathy (IgAN) patients with:
1. DP \>1 g with haematuria (\>5 RBC/HPF)
2. DP \<1 g with haematuria AND probability of starting dialysis within 5 years \>11% (estimated by the International risk-prediction tool in IgAN) AND at least one of the following histologic changes: at least one of the following histologic changes: mesangial proliferation, endocapillary hypercellularity, cellular crescents
Exclusion Criteria:
1. Age \<18 or \>75 years;
2. eGFR ≤20 ml/min/1.73m2
3. Patients with mild renal lesions (M0, E0, S0, T0, C0), minor urinary findings, DP \<1.0 g
4. Contraindications to IST or TE
5. Patients with any co-existing kidney disease
6. Patients with secondary IgAN (Schoenlein-Henoch purpura, liver cirrhosis, etc.)
7. Patients with diabetes mellitus
8. Any clinically significant acute illness within 60 days prior to kidney biopsy (including infection, aseptic necrosis of any bone, patients with myocardial infarction or cerebrovascular stroke, other conditions that can be exacerbated by corticosteroids
9. Incomplete empiric IST administered prior to kidney biopsy
10. Pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07074951
Study Brief:
Protocol Section:
NCT07074951