Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT07750665

FXS6837 for the Treatment for IgAN Patients(Longterm Study)

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.

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

1. Have completed the study treatment in FXS6837-IIb-201, and are evaluated by the investigator to have an anticipated benefit exceeding risk with long-term FXS6837 treatment; 2. eGFR (CKD-EPI) ≥ 30 mL/min/1.73 m2 at screening; 3. Vaccinated against Neisseria meningitidis and Streptococcus pneumoniae as required by the previous study (Booster vaccination should be administered promptly in accordance with vaccination guidelines and local immunization authority requirements if the vaccine protection period fails to cover the treatment duration of this study); 4. Able to continue optimized treatment with RASi, SGLT2i, ERA, and hydroxychloroquine throughout the study with stable prescribed dosing; 5. Have a detailed understanding of the nature, significance, possible benefits, potential inconveniences, and potential risks of the trial, and voluntarily participate in this clinical trial; Able to communicate well with the investigators and comply with the requirements of the entire study; And signed a written ICF; 6. Participants of reproductive potential commit to having no plans for pregnancy or sperm/egg donation from screening until 1 month (female participants) or 3 months (male participants) after the last dose and voluntarily take effective physical contraceptive methods (including partners). Exclusion criteria: 1. Known or suspected by investigators to have immunodeficiency diseases or hereditary complement deficiency; 2. Any organ transplant recipients (except corneal transplant); 3. Concomitant major systemic diseases, including but not limited to: advanced heart disease (such as NYHA class IV), severe pulmonary disease (such as severe pulmonary hypertension [WHO class IV]), active hepatitis, or other major systemic diseases assessed by investigators as unable to participate in this study; 4. History of malignant tumors within 5 years before screening (except carcinoma in situ and thyroid cancer assessed by investigators as curatively resected).

  • 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.

Treatment and study plan

FXS6837 Capsule

Drug

FXS6837 capsule orally taken according to protocol for 2 years

Primary outcomes

  1. Incidence and severity of adverse events

    Time frame: through study completion, an average of 2 years

Secondary outcomes

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

    Time frame: through study completion, an average of 2 years

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

    Time frame: through study completion, an average of 2 years

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

    Time frame: through study completion, an average of 2 years

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

    Time frame: through study completion, an average of 2 years

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

    Time frame: through study completion, an average of 2 years

  6. Trough plasma concentration of FXS6837

    Time frame: through study completion, an average of 2 years

  7. Complement AP activity in peripheral blood at each visit point

    Time frame: through study completion, an average of 2 years

  8. Levels and changes of PD biomarkers in plasma and urine at each visit

    Time frame: through study completion, an average of 2 years

Study contacts

Contact information is provided by the study sponsor or research team.

Jicheng Prof. Lv, Doctor

CONTACT

[email protected]

+86 10 83572211

Yang Dr. Li, Doctor

CONTACT

[email protected]

+86 10 83572211

Sponsors and collaborators

Lead sponsor

Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.

Industry

Registry information

Official study title

A Study to Evaluate the Long-term Efficacy and Safety of FXS6837 in IgAN Patients

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Aug 6, 2026
Registry last updated
Aug 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.