FXS6837 for the Treatment of IgAN Patients (NCT07502638) | Clinical Trial Compass
Not Yet RecruitingPhase 2
FXS6837 for the Treatment of IgAN Patients
China60 participantsStarted 2026-03-31
Plain-language summary
This is a multicenter, randomized, double-blind, placebo controlled Phase IIb study to explore the efficacy and safety of FXS6837 capsules in IgAN patients. About 60 patients dignosed with primary IgAN will be enrolled and randomized to three cohorts and take different dosage of FXS6837 or placebo capsules orally according to protocol.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Adult male or female patients aged ≥18 years with biopsy-confirmed primary IgA nephropathy (IgAN), meeting all of the following:
✓. A qualifying renal biopsy performed within the past 8 years;
✓. ≤50% tubulointerstitial fibrosis;
✓. Crescent formation present in ≤50% of glomeruli;
✓. If a historical biopsy is not available, a biopsy may be performed during screening.
✓. Estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m² at screening and at the end of the run-in period.
✓. Urine protein-to-creatinine ratio (UPCR) ≥0.75 g/g at screening and at the end of the run-in period.
✓. Vaccination against Neisseria meningitidis and Streptococcus pneumoniae is required prior to initiation of study treatment. If not previously vaccinated or if a booster is required, 5. vaccination should be administered according to local regulations at least 2 weeks prior to first dose. If treatment must begin earlier, prophylactic antibiotic therapy should be initiated.
Exclusion criteria
✕. Secondary IgA nephropathy (IgAN), as defined by the investigator.
✕. Rapidly progressive IgAN, defined as ≥50% decline in eGFR (CKD-EPI) within 3 months, or \<50% decline but considered by the investigator to be at risk of rapid renal function deterioration.
✕. Other systemic diseases associated with proteinuria or chronic kidney disease (e.g., diabetic nephropathy, lupus nephritis, ANCA-associated vasculitis), or severe urinary tract obstruction or dysuria.
What they're measuring
1
Ratio to baseline in Urine Protein to Creatinine Ratio (sampled from 24h urine collection) at Day180
Timeframe: baseline and Day180
Trial details
NCT IDNCT07502638
SponsorShanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
✕. Prior treatment with immunosuppressive agents, including but not limited to cyclophosphamide, rituximab, infliximab, eculizumab, canakinumab, mycophenolate mofetil (MMF), mycophenolate sodium (MPS), cyclosporine, tacrolimus, sirolimus, everolimus, or systemic corticosteroids within 90 days (or 5 half-lives, whichever is longer) prior to first dose.
✕. Prior treatment with oral budesonide (Nefecon®) within 6 months prior to first dose.
✕. Prior treatment with other complement inhibitors within 30 days (or 5 half-lives, whichever is longer) prior to first dose.
✕. Positive test results for HIV; active syphilis infection; chronic hepatitis B infection (HBsAg positive with HBV DNA \> lower limit of quantification \[LOQ\]); or hepatitis C infection (positive HCV antibody with detectable HCV RNA).