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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

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).

  1. 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.

Jicheng Prof. Lv, Doctor contact

+86 10 83572211

jichenglv@bjmu.edu.cn

Yang Dr. Li, Doctor contact

+86 10 83572211

liyang_3337@163.com

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

Other trials in China

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 groups in NCT07750665
Study groupRoleWhat they receive
experimental:FXS6837ExperimentalFXS6837 Capsule
Receives: Drug: FXS6837 Capsule

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence and severity of adverse events

    Measured: through study completion, an average of 2 years

Secondary outcomes (8)
  1. Ratio of urine protein-to-creatinine ratio (UPCR) to baseline at each visit

    Measured: through study completion, an average of 2 years

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

    Measured: through study completion, an average of 2 years

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

    Measured: through study completion, an average of 2 years

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

    Measured: through study completion, an average of 2 years

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

    Measured: through study completion, an average of 2 years

  6. Trough plasma concentration of FXS6837

    Measured: through study completion, an average of 2 years

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

    Measured: through study completion, an average of 2 years

  8. 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.

  1. First posted6 Aug 2026
  2. Study start30 Sep 2026 (estimated)
  3. Primary completion13 Nov 2029 (estimated)
  4. Study completion4 Jan 2030 (estimated)

Resources

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)
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

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.

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