FXS6837 for the Treatment for IgAN Patients（Longterm Study）

NCT07750665 | Not Yet Recruiting Phase 2

• 1 other identifier: FXS6837-IgAN-202
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicenter, open-label study to evaluate the long-term safety and efficacy of FXS6837 capsules in primary IgAN patients. About 60 IgAN patients who had received and completed FXS6837-IIb-201 study treatment will be enrolled to take FXS6837 capsules orally according to protocol for 2 years.

Conditions

Primary IgAN

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of adverse events

  through study completion, an average of 2 years

Secondary Outcomes (8)

• Ratio of urine protein-to-creatinine ratio (UPCR) to baseline at each visit

  through study completion, an average of 2 years

• Ratio of urine albumin-to-creatinine ratio (UACR) to baseline at each visit

  through study completion, an average of 2 years

• Ratio of 24-h urine protein (24 hour-UPE) to baseline at each visit

  through study completion, an average of 2 years

• Ratio of 24-h urine albumin excretion (24 hour-UAE) to baseline at each visit

  through study completion, an average of 2 years

• Change from baseline in estimated glomerular filtration rate (eGFR) at each visit

  through study completion, an average of 2 years

Study Arms (1)

experimental:FXS6837

EXPERIMENTAL

FXS6837 Capsule

Drug: FXS6837 Capsule

Interventions

FXS6837 Capsule DRUG

FXS6837 capsule orally taken according to protocol for 2 years

experimental:FXS6837

Eligibility Criteria

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

You may not qualify if:

• \. Previous history of Neisseria meningitidis or recurrent Streptococcus pneumoniae infection ; 6. Suspected or known history of allergies to similar ingredients of the study drug or any ingredient in the study drug; 7. Pregnant or lactating women or those with positive pregnancy test results; 8. Other conditions deemed by the investigator that may potentially interfere with study conduct, impose additional risks to the participant, or render the individual ineligible for study participation.

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 Prof. Lv, Doctor

CONTACT

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

Yang Dr. Li, Doctor

CONTACT

+86 10 83572211; liyang_3337@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2026
• First Posted: August 6, 2026
• Study Start (Estimated): September 30, 2026
• Primary Completion (Estimated): November 13, 2029
• Study Completion (Estimated): January 4, 2030
• Last Updated: August 6, 2026

Record last verified: 2026-07

Locations

CN (1)