A Phase 2 interventional study of FXS6837 Capsule in Primary IgAN, sponsored by Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-06.
Sponsored by Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. (part of Fosun Pharma) · Phase 2, Interventional, and Treatment
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.
Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. is the lead sponsor of 34 studies on the registry; 21 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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. (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 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 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 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).
5. 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FXS6837 Capsule
Drug: FXS6837 Capsule
FXS6837 capsule orally taken according to protocol for 2 years
Incidence and severity of adverse events
Time frame: through study completion, an average of 2 years
Ratio of urine protein-to-creatinine ratio (UPCR) to baseline at each visit
Time frame: through study completion, an average of 2 years
Ratio of urine albumin-to-creatinine ratio (UACR) to baseline at each visit
Time frame: through study completion, an average of 2 years
Ratio of 24-h urine protein (24 hour-UPE) to baseline at each visit
Time frame: through study completion, an average of 2 years
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
Change from baseline in estimated glomerular filtration rate (eGFR) at each visit
Time frame: through study completion, an average of 2 years
Trough plasma concentration of FXS6837
Time frame: through study completion, an average of 2 years
Complement AP activity in peripheral blood at each visit point
Time frame: through study completion, an average of 2 years
Levels and changes of PD biomarkers in plasma and urine at each visit
Time frame: through study completion, an average of 2 years
Start is estimated for Sep 2026; primary completion for Nov 2029, 37 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: FXS6837
Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. →