Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • FXS6837 Dose 1

    Drug

    FXS6837 taken orally once a day

  • FXS6837 Dose 2

    Drug

    FXS6837 taken orally once a day

  • Placebo Capsule

    Drug

    Placebo taken orally once a day

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Arm1：FXS6837 Dose 1Experimental treatment 1 intervention
Group B: Arm2：FXS6837 Dose 2Experimental treatment 1 intervention
Group C: Arm3：PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Ratio to baseline in Urine Protein to Creatinine Ratio (sampled from 24h urine collection) at Day180

Time frame
baseline and Day180

Secondary outcomes

1

Ratio to baseline in Urine Protein to Creatinine Ratio at Day90

Time frame
baseline and Day90
2

Ratio to baseline in Urine Protein to Creatinine Ratio

Time frame
up to Day180
3

Ratio to baseline in Urine Albumin to Creatinine Ratio

Time frame
up to Day180
4

Ratio to baseline in Urinary protein excretion（UPE）

Time frame
up to Day180

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: