FXS6837 for the Treatment of IgAN Patients

NCT07502638 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: FXS6837-IIb-201
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

IgAN

Outcome Measures

Primary Outcomes (1)

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

  baseline and Day180

Secondary Outcomes (7)

• Ratio to baseline in Urine Protein to Creatinine Ratio at Day90

  baseline and Day90

• Ratio to baseline in Urine Protein to Creatinine Ratio

  up to Day180

• Ratio to baseline in Urine Albumin to Creatinine Ratio

  up to Day180

• Ratio to baseline in Urinary protein excretion（UPE）

  up to Day180

• Ratio to baseline in Urinary Albumin excretion（UAE）

  up to Day180

Study Arms (3)

Arm1：FXS6837 Dose 1

EXPERIMENTAL

Once daily

Drug: FXS6837 Dose 1

Arm2：FXS6837 Dose 2

EXPERIMENTAL

Once daily

Drug: FXS6837 Dose 2

Arm3：Placebo

PLACEBO COMPARATOR

Once daily

Drug: Placebo Capsule

Interventions

FXS6837 Dose 1 DRUG

FXS6837 taken orally once a day

Also known as: Dose 1

Arm1：FXS6837 Dose 1

FXS6837 Dose 2 DRUG

FXS6837 taken orally once a day

Also known as: Dose 2

Arm2：FXS6837 Dose 2

Placebo Capsule DRUG

Placebo taken orally once a day

Also known as: Placebo

Arm3：Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patients must have received a stable dose of angiotensin-converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARB), at the locally approved maximum daily dose or maximally tolerated dose (per investigator judgment), for at least 90 days prior to first dose. If receiving sodium-glucose cotransporter-2 inhibitors (SGLT2i), endothelin receptor antagonists (ERA), or hydroxychloroquine, doses must also be stable for at least 90 days prior to first dose (per investigator judgment).

You may not qualify if:

• 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.
• 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).
• Active tuberculosis at screening.
• Clinically significant abnormal liver function at screening, defined as any of the following: ALT, AST, GGT, or ALP \>3 × upper limit of normal (ULN), or total bilirubin \>2 × ULN.
• History of meningococcal infection.
• Active systemic bacterial, viral (including COVID-19), or fungal infection within 14 days prior to first dose, or body temperature \>38°C within 7 days prior to first dose.

Sponsors & Collaborators

• Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Study Officials

• Jicheng Lv, Doctor

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jicheng LV, Doctor

CONTACT

+86-10-83572211; jichenglv@bjmu.edu.cn

Yang Li, Doctor

CONTACT

+86-10-83572211; liyang_3337@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2026
• First Posted: March 31, 2026
• Study Start: March 31, 2026
• Primary Completion (Estimated): September 12, 2027
• Study Completion (Estimated): November 14, 2027
• Last Updated: March 31, 2026

Record last verified: 2026-03

Locations

CN (1)