2026-08-30
critical
Study Identification, Study Status, Study Description, Outcome Measures, Eligibility, Contacts/Locations v1
Recruitment opened
Primary endpoint(s) modified1 entry, revised
WasTime to first occurrence of proteinuria relapse
NowTime to first composite disease relapse
Start dateestimated 2026-05-01→confirmed 2026-06-23
Study sites0→1
Eligibility criteria+278 characters
Inclusion Criteria:
Diagnosed primary IgAN with biopsy verification.;
Female or male participants ≥18 years of age.;
Completion of ≥9 months of Nefecon 16 mg QD at the Baselinebaseline visit.;
Proteinuria ≥ 1g/d prior to initiation of Nefecon;
Proteinuria<0.5 g/day (or UPCR <0.5 g/g) at screening and randomization visit;
eGFR ≥30 ml/min/1.73m²
at screening;
On stable treatment with supportive treatment（ (including RAASi, SGLT2i, ERA）) for at least 1 month prior to the Baselinebaseline visit;
Exclusion Criteria:
Systemic diseases that may cause mesang [...] l immunoglobulin A deposition, including but [...]
Secondary endpoints5 to 6 entries
All-cause mortality
Study title-56 characters
Efficacy and Safety of Nefecon on Prevention of Relapse of IgA Nephropathy: a Randomized, Double-blinded, Placebo-Controlled Trial