Primary IgANPhase 2NCT07750665
FXS6837 for the Treatment for IgAN Patients(Longterm Study)
A Phase 2 study testing FXS6837 Capsule in people with Primary IgAN, run by Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary IgAN
- What is being tested?
- FXS6837 Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2026to 4 Jan 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Dr. Wang, +86 10 66119025 ext. 801, bdyyec@163.com
Dr. Yu, +86 10 66119025 ext. 802, bdyyec@163.com
About this study
Official title: A Study to Evaluate the Long-term Efficacy and Safety of FXS6837 in IgAN Patients
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
- Being tested
- FXS6837 Capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FXS6837 CapsuleDrug
FXS6837 capsule orally taken according to protocol for 2 years
| Study group | Role | What they receive |
|---|---|---|
| experimental:FXS6837 | Experimental | FXS6837 Capsule Receives: Drug: FXS6837 Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events
Measured: through study completion, an average of 2 years
Secondary outcomes (8)
Ratio of urine protein-to-creatinine ratio (UPCR) to baseline at each visit
Measured: through study completion, an average of 2 years
Ratio of urine albumin-to-creatinine ratio (UACR) to baseline at each visit
Measured: through study completion, an average of 2 years
Ratio of 24-h urine protein (24 hour-UPE) to baseline at each visit
Measured: through study completion, an average of 2 years
Ratio of 24-h urine albumin excretion (24 hour-UAE) to baseline at each visit
Measured: through study completion, an average of 2 years
Change from baseline in estimated glomerular filtration rate (eGFR) at each visit
Measured: through study completion, an average of 2 years
Trough plasma concentration of FXS6837
Measured: through study completion, an average of 2 years
Complement AP activity in peripheral blood at each visit point
Measured: through study completion, an average of 2 years
Levels and changes of PD biomarkers in plasma and urine at each visit
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start30 Sep 2026 (estimated)
- Primary completion13 Nov 2029 (estimated)
- Study completion4 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary IgANStudies of the same condition, open and under way.
- More trials run by Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jicheng Lv, Doctor, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07750665
- Sponsor's protocol ID
- FXS6837-IgAN-202
- Status last verified
- Jul 2026
- First submitted
- 2 Aug 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Long-term Efficacy and Safety of FXS6837 in IgAN Patients
- ClinicalTrials.gov ID
- NCT07750665
- Acronym / sponsor ID
- FXS6837-IgAN-202
- Conditions
- Primary IgAN
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 13 Nov 2029 (estimated)
- Study completion
- 4 Jan 2030 (estimated)
- First posted
- 6 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental:FXS6837 | Experimental | Drug: FXS6837 CapsuleFXS6837 Capsule |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FXS6837 CapsuleFXS6837 capsule orally taken according to protocol for 2 years | Drug | experimental:FXS6837 |
Primary outcome
Incidence and severity of adverse events
Time frame: through study completion, an average of 2 years
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
Related trials for Primary IgAN
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
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A Study of Mezagitamab in Adults With Kidney Condition Called IgA Nephropathy
Kidney Disease
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
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A Study to Evaluate the Efficacy and Safety of Sefaxersen (RO7434656) in Participants With Primary Immunoglobulin A (IgA) Nephropathy at High Risk of Progression
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A Study to Evaluate the Effect of ARGX-121 on the Change in Proteinuria in Adult Participants With IgAN
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jicheng Lv, Doctor principal investigator
Peking University First Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FXS6837 Capsule in people with Primary IgAN, run by Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jicheng Prof. Lv, Doctor (+86 10 83572211, jichenglv@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events (time frame: through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.