IgANPhase 2NCT07502638
FXS6837 for the Treatment of IgAN Patients
A Phase 2 study testing FXS6837 Dose 1 and FXS6837 Dose 2 in people with IgAN, run by Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. at 1 site in China.
Trial summary
This is a multicenter, randomized, double-blind, placebo controlled Phase IIb study to explore the efficacy and safety of FXS6837 capsules in IgAN patients. About 60 patients dignosed with primary IgAN will be enrolled and randomized to three cohorts and take different dosage of FXS6837 or placebo capsules orally… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IgAN
- What is being tested?
- FXS6837 Dose 1 and FXS6837 Dose 2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 31 Mar 2026to 14 Nov 2027
- 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
Who may be able to join
- Adult male or female patients aged ≥18 years with biopsy-confirmed primary IgA nephropathy (IgAN), meeting all of the following:
- A qualifying renal biopsy performed within the past 8 years;
- ≤50% tubulointerstitial fibrosis;
- Crescent formation present in ≤50% of glomeruli;
- If a historical biopsy is not available, a biopsy may be performed during screening.
- Estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m² at screening and at the end of the run-in period.
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- Urine protein-to-creatinine ratio (UPCR) ≥0.75 g/g at screening and at the end of the run-in period.
- Vaccination against Neisseria meningitidis and Streptococcus pneumoniae is required prior to initiation of study treatment. If not previously vaccinated or if a booster is required, 5. vaccination should be administered according to local regulations at least 2 weeks prior to first dose. If treatment must begin earlier, prophylactic antibiotic therapy should be initiated.
- Patients must have received a stable dose of angiotensin-converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARB), at the locally approved maximum daily dose or maximally tolerated dose (per investigator judgment), for at least 90 days prior to first dose. If receiving sodium-glucose cotransporter-2 inhibitors (SGLT2i), endothelin receptor antagonists (ERA), or hydroxychloroquine, doses must also be stable for at least 90 days prior to first dose (per investigator judgment).
Who cannot join
- Secondary IgA nephropathy (IgAN), as defined by the investigator.
- Rapidly progressive IgAN, defined as ≥50% decline in eGFR (CKD-EPI) within 3 months, or <50% decline but considered by the investigator to be at risk of rapid renal function deterioration.
- Other systemic diseases associated with proteinuria or chronic kidney disease (e.g., diabetic nephropathy, lupus nephritis, ANCA-associated vasculitis), or severe urinary tract obstruction or dysuria.
- Prior treatment with immunosuppressive agents, including but not limited to cyclophosphamide, rituximab, infliximab, eculizumab, canakinumab, mycophenolate mofetil (MMF), mycophenolate sodium (MPS), cyclosporine, tacrolimus, sirolimus, everolimus, or systemic corticosteroids within 90 days (or 5 half-lives, whichever is longer) prior to first dose.
- Prior treatment with oral budesonide (Nefecon®) within 6 months prior to first dose.
- Prior treatment with other complement inhibitors within 30 days (or 5 half-lives, whichever is longer) prior to first dose.
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- Positive test results for HIV; active syphilis infection; chronic hepatitis B infection (HBsAg positive with HBV DNA > lower limit of quantification [LOQ]); or hepatitis C infection (positive HCV antibody with detectable HCV RNA).
- Active tuberculosis at screening.
- Clinically significant abnormal liver function at screening, defined as any of the following: ALT, AST, GGT, or ALP >3 × upper limit of normal (ULN), or total bilirubin >2 × ULN.
- History of meningococcal infection.
- Active systemic bacterial, viral (including COVID-19), or fungal infection within 14 days prior to first dose, or body temperature >38°C within 7 days prior to first dose.
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
Wang, +86-10-66119025 ext. 801, bdyyec@163.com
Yu, +86-10-66119025 ext. 802, bdyyec@163.com
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of FXS6837 in IgAN Patients
This is a multicenter, randomized, double-blind, placebo controlled Phase IIb study to explore the efficacy and safety of FXS6837 capsules in IgAN patients. About 60 patients dignosed with primary IgAN will be enrolled and randomized to three cohorts and take different dosage of FXS6837 or placebo capsules orally according to protocol.
Read the detailed description
This is a multicenter, randomized, double-blind, placebo-controlled study in approximately 60 patients with primary IgA nephropathy (IgAN).
Participants receiving background therapy will be randomized in a 1:1:1 ratio to receive FXS6837 capsules dose 1,dose 2, or placebo, administered orally once daily.
The study aims to evaluate the efficacy and safety of FXS6837 in patients with primary IgAN and to identify the optimal clinical dose.
- Conditions
- IgAN
- Being tested
- FXS6837 Dose 1, FXS6837 Dose 2, Placebo Capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FXS6837 Dose 1Drug
Also called Dose 1
FXS6837 taken orally once a day
FXS6837 Dose 2Drug
Also called Dose 2
FXS6837 taken orally once a day
Placebo CapsuleDrug
Also called Placebo
Placebo taken orally once a day
| Study group | Role | What they receive |
|---|---|---|
| Arm1：FXS6837 Dose 1 | Experimental | Once daily Receives: Drug: FXS6837 Dose 1 |
| Arm2：FXS6837 Dose 2 | Experimental | Once daily Receives: Drug: FXS6837 Dose 2 |
| Arm3：Placebo | Placebo comparator | Once daily Receives: Drug: Placebo Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio to baseline in Urine Protein to Creatinine Ratio (sampled from 24h urine collection) at Day180
Measured: baseline and Day180
Secondary outcomes (7)
Ratio to baseline in Urine Protein to Creatinine Ratio at Day90
Measured: baseline and Day90
Ratio to baseline in Urine Protein to Creatinine Ratio
Measured: up to Day180
Ratio to baseline in Urine Albumin to Creatinine Ratio
Measured: up to Day180
Ratio to baseline in Urinary protein excretion（UPE）
Measured: up to Day180
Ratio to baseline in Urinary Albumin excretion（UAE）
Measured: up to Day180
Change from baseline of serum creatinine
Measured: up to Day180
Change from baseline of estimated glomerular filtration rate（eGFR）
Measured: up to Day180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start31 Mar 2026 (estimated)
- Primary completion12 Sep 2027 (estimated)
- Study completion14 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- 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
- NCT07502638
- Sponsor's protocol ID
- FXS6837-IIb-201
- Status last verified
- Mar 2026
- First submitted
- 15 Mar 2026
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of FXS6837 in IgAN Patients
- ClinicalTrials.gov ID
- NCT07502638
- Acronym / sponsor ID
- FXS6837-IIb-201
- Conditions
- 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
- 31 Mar 2026 (estimated)
- Primary completion
- 12 Sep 2027 (estimated)
- Study completion
- 14 Nov 2027 (estimated)
- First posted
- 31 Mar 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, randomized, double-blind, placebo controlled Phase IIb study to explore the efficacy and safety of FXS6837 capsules in IgAN patients. About 60 patients dignosed with primary IgAN will be enrolled and randomized to three cohorts and take different dosage of FXS6837 or placebo capsules orally according to protocol.
Detailed description
This is a multicenter, randomized, double-blind, placebo-controlled study in approximately 60 patients with primary IgA nephropathy (IgAN).
Participants receiving background therapy will be randomized in a 1:1:1 ratio to receive FXS6837 capsules dose 1,dose 2, or placebo, administered orally once daily.
The study aims to evaluate the efficacy and safety of FXS6837 in patients with primary IgAN and to identify the optimal clinical dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm1：FXS6837 Dose 1 | Experimental | Drug: FXS6837 Dose 1Once daily |
| Arm2：FXS6837 Dose 2 | Experimental | Drug: FXS6837 Dose 2Once daily |
| Arm3：Placebo | Placebo comparator | Drug: Placebo CapsuleOnce daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adult male or female patients aged ≥18 years with biopsy-confirmed primary IgA nephropathy (IgAN), meeting all of the following:
- Estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m² at screening and at the end of the run-in period.
- Urine protein-to-creatinine ratio (UPCR) ≥0.75 g/g at screening and at the end of the run-in period.
- Vaccination against Neisseria meningitidis and Streptococcus pneumoniae is required prior to initiation of study treatment. If not previously vaccinated or if a booster is required, 5. vaccination should be administered according to local regulations at least 2 weeks prior to first dose. If treatment must begin earlier, prophylactic antibiotic therapy should be initiated.
- Patients must have received a stable dose of angiotensin-converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARB), at the locally approved maximum daily dose or maximally tolerated dose (per investigator judgment), for at least 90 days prior to first dose. If receiving sodium-glucose cotransporter-2 inhibitors (SGLT2i), endothelin receptor antagonists (ERA), or hydroxychloroquine, doses must also be stable for at least 90 days prior to first dose (per investigator judgment).
Key exclusion criteria (11 listed)
- Secondary IgA nephropathy (IgAN), as defined by the investigator.
- Rapidly progressive IgAN, defined as ≥50% decline in eGFR (CKD-EPI) within 3 months, or <50% decline but considered by the investigator to be at risk of rapid renal function deterioration.
- Other systemic diseases associated with proteinuria or chronic kidney disease (e.g., diabetic nephropathy, lupus nephritis, ANCA-associated vasculitis), or severe urinary tract obstruction or dysuria.
- Prior treatment with immunosuppressive agents, including but not limited to cyclophosphamide, rituximab, infliximab, eculizumab, canakinumab, mycophenolate mofetil (MMF), mycophenolate sodium (MPS), cyclosporine, tacrolimus, sirolimus, everolimus, or systemic corticosteroids within 90 days (or 5 half-lives, whichever is longer) prior to first dose.
- Prior treatment with oral budesonide (Nefecon®) within 6 months prior to first dose.
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 Dose 1Also: Dose 1FXS6837 taken orally once a day | Drug | Arm1：FXS6837 Dose 1 |
| FXS6837 Dose 2Also: Dose 2FXS6837 taken orally once a day | Drug | Arm2：FXS6837 Dose 2 |
| Placebo CapsuleAlso: PlaceboPlacebo taken orally once a day | Drug | Arm3：Placebo |
Primary outcome
Ratio to baseline in Urine Protein to Creatinine Ratio (sampled from 24h urine collection) at Day180
Time frame: baseline and Day180
7 secondary outcomes
Ratio to baseline in Urine Protein to Creatinine Ratio at Day90
Time frame: baseline and Day90
Ratio to baseline in Urine Protein to Creatinine Ratio
Time frame: up to Day180
Ratio to baseline in Urine Albumin to Creatinine Ratio
Time frame: up to Day180
Ratio to baseline in Urinary protein excretion（UPE）
Time frame: up to Day180
Ratio to baseline in Urinary Albumin excretion（UAE）
Time frame: up to Day180
Change from baseline of serum creatinine
Time frame: up to Day180
Change from baseline of estimated glomerular filtration rate（eGFR）
Time frame: up to Day180
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 31 Mar 2026.
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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 Dose 1 and FXS6837 Dose 2 in people with 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?
The sponsor lists 9 inclusion and 11 exclusion criteria. 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 31 Mar 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. Some participants in this study may receive a placebo. 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 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?
Ratio to baseline in Urine Protein to Creatinine Ratio (sampled from 24h urine collection) at Day180 (time frame: baseline and Day180). 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 31 Mar 2026.