FXS6837 for the Treatment of IgAN Patients
ConditionIgAN
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
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.
Trial design
Treatments tested in this trial
- FXS6837 Dose 1
- FXS6837 Dose 2
- Placebo Capsule
Treatment groups
60 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov