AzTrials
AzTrials

IgA NephropathyPhase 2NCT07634744

A Phase IIa Study in Primary IgA Nephropathy Patients

A Phase 2 study testing XH-S003 Capsule in people with IgA Nephropathy, run by Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a phase IIa, multicenter, single-arm, open-label study to evaluate the safety and efficacy of XH-S003 in patients with primary IgA nephropathy Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
IgA Nephropathy
What is being tested?
XH-S003 Capsule
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteChina
Study dates
31 Dec 2024to 23 Apr 2026
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Subjects must meet the following inclusion criteria:
  • ● Male and female patients aged ≥18 years with a renal biopsy-confirmed diagnosis of primary IgA nephropathy:
  • For patients with eGFR (CKD-EPI) ≥ 45 mL/min/1.73m2 at screening, a renal pathology biopsy within 10 years confirmed primary IgA nephropathy;
  • For screening, eGFR (CKD-EPI) ≥30 and <45 mL/min/1.73m2 patients, within 2 years, diagnosed with primary IgA nephropathy through renal pathology biopsy;
  • Renal pathology biopsy shows tubulointerstitial fibrosis < 50%;
  • Renal pathology biopsy shows crescent formation in < 50% of glomeruli;
Show all 13Show fewer
  • If previous renal pathology biopsy results are unavailable, a biopsy needs to be performed during the screening period;
  • During screening and after completion of import eGFR (CKD-EPI) ≥ 30 mL/min/1.73 m2;
  • During screening and after completion of import, UPCR ≥ 0.75 g/g;
  • Before the first administration of medication, vaccination against Neisseria meningitidis and Streptococcus pneumoniae is required. If the patient has not been vaccinated before, or requires a booster, the vaccine should be administered at least 2 weeks prior to the first administration of medication. If the first administration of medication must begin earlier than 2 weeks after vaccination, prophylactic antibiotic therapy should be used until at least 2 weeks after vaccination;
  • Before the first administration, patients must have been on a stable treatment with the maximum tolerated dose of ACEi/ARB and SGLT2i for at least 90 days, and this treatment should remain unchanged during the study period. Additionally, if the patient is using diuretics or other antihypertensive treatments, the medication dosage should also be stable for at least 90 days before the first administration and remain unchanged during the study period;
  • After thoroughly understanding the nature, significance, potential benefits, possible inconveniences, and potential risks of the trial, and voluntarily participating in this clinical trial, the participant is able to communicate well with the researchers, comply with the requirements of the entire study, and has signed a written informed consent form.
  • Subjects of childbearing potential commit to having no plans for procreation, sperm or egg donation from screening to 1 month after the last dose (for females) or 3 months (for males), and voluntarily agree to use effective physical contraception methods (including their partners).

Who cannot join

  • Secondary IgAN or those in whom secondary factors cannot be ruled out by investigator assessment;
  • Rapidly progressive IgA nephropathy (such as a decrease in eGFR (CKD-EPI) by ≥50% within 3 months, or less than 50% but with a risk of rapid decline in kidney function as assessed by the investigator);
  • Patients assessed by researchers to have other possible systemic diseases causing proteinuria (such as diabetic nephropathy, autoimmune diseases, antineutrophil cytoplasmic antibody-associated vasculitis, etc.); or those with severe urinary tract obstruction or dysuria; or other chronic kidney diseases (with or without kidney failure);
  • Known or suspected coalescence of immune deficiency diseases, hereditary complement deficiency as assessed by the researcher;
  • Any organ transplant recipient (excluding corneal transplant);
  • According to the investigator's assessment, blood pressure was inadequately controlled at screening (sitting blood pressure systolic >150 mmHg or blood pressure diastolic >90 mmHg);
Show all 27Show fewer
  • Used immunosuppressants or other immunomodulatory drugs within 90 days prior to the first administration, or still within 5 half-lives of the drug, whichever is longer, specifically including but not limited to cyclophosphamide, rituximab, infliximab, eculizumab, canakinumab, Mycophenolate Mofetil, Ciclosporin, tacrolimus, sirolimus, everolimus, systemic corticosteroids, etc.
  • Patients who have been treated with Endothelin receptor antagonists within the first 90 days before initial medication;
  • Individuals who have taken any decocted herbal products or used Jinshuibao, Bailing capsules, Huangkui capsules, Chinese patent medicines with immunosuppressive action (such as Tripterygium wilfordii preparations, Sinomenium acutum preparations, etc.), or other herbal products/Chinese patent medicines assessed by the researcher to have an impact on the trial assessment within 90 days prior to the first medication;
  • Patients who have previously or are currently receiving oral budesonide sustained-release tablets (Nefecon®, Nifukang®) for the treatment of IgAN;
  • During screening, individuals who are currently using hydroxychloroquine but have unstable treatment (except those who have been on stable treatment for at least 3 months prior to the first administration and can maintain this treatment unchanged throughout the study) or those planning to start using hydroxychloroquine during the study;
  • Patients with coalescence of systemic major diseases, including but not limited to: advanced stage heart disorder (such as NYHA Class IV), severe lung disease (such as severe pulmonary arterial hypertension (WHO Class IV), active hepatitis, or other systemic major diseases deemed unsuitable for participation in this study by the investigator;
  • During screening, individuals with significantly abnormal liver function: any parameter of ALT, AST, GGT, or alkaline phosphatase > 3 times the upper limit of normal (ULN); serum bilirubin total > 2 times ULN;14. Screening for human immunodeficiency virus (HIV) infection (HIV antibody positive), active syphilis infection, hepatitis B virus infection (hepatitis B surface antigen positive), active hepatitis C virus infection;
  • Active or latent tuberculosis during screening;
  • Individuals with a history of malignant neoplasm within the 5 years prior to screening (excluding carcinoma in situ and thyroid cancer that have been assessed by the researcher as having been radically resected);
  • History of Neisseria meningitidis infection;
  • Chronic active or recurrent infections within 1 year prior to screening, deemed unsuitable for participation in this study by the investigator, such as liver abscess, pyelonephritis, etc.;
  • Individuals with active systemic bacterial, viral (including COVID-19), or fungal infections requiring intravenous antibiotic treatment within 2 weeks prior to the first medication; those with an axillary body temperature >38°C within 7 days prior to the first medication;
  • Severe trauma or major surgery history within 3 months prior to screening, or plans to undergo major surgery during the trial;
  • History of blood donation or severe blood loss (blood volume ≥400mL) within 3 months prior to screening, or having received a transfusion within 3 months prior to screening;
  • Suspected or confirmed allergy to similar components of the investigational drug product or any components within the investigational drug product;
  • Pregnant or lactating women, or those with a positive pregnancy test;
  • History of drug abuse or substance use.
  • History of alcoholism within the 6 months prior to screening (average weekly consumption of ≥14 units of alcohol: 1 unit = 285 mL of beer; or 25 mL of spirits; or 125 mL of wine);
  • Participated in other clinical investigational drug trials (or still within 5 half-lives of the drug, whichever is longer) or medical device clinical trials within 30 days prior to screening, or plans to participate in other clinical trials during the study period, or if the investigator's assessment indicates the presence of residual effects;
  • Subjects assessed by the researcher to have diseases or medical conditions that affect drug absorption, distribution, metabolism, and excretion or may reduce compliance, such as a history of severe intestinal diseases, major gastrointestinal surgery, or the presence of dysphagia;
  • Researchers believe that any condition that may prevent subjects from completing this study or pose significant risks to the subjects, or patients deemed unsuitable to participate in this study by the researchers

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking University First Hospital

    Beijing

Other trials in China

About this study

Official title: A Multicenter, Single-arm, Open-label Study to Evaluate the Safety and Efficacy of XH-S003 in Patients With Primary IgA Nephropathy

This is a phase IIa, multicenter, single-arm, open-label study to evaluate the safety and efficacy of XH-S003 in patients with primary IgA nephropathy

Conditions
IgA Nephropathy
Being tested
XH-S003 Capsule
Medical subject headings
Glomerulonephritis, IGA

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • XH-S003 CapsuleDrug

    Oral， once daily

Study groups in NCT07634744
Study groupRoleWhat they receive
XH-S003 CapsuleExperimental100mg and 25mg XH-S003 capsules QD Oral.
Receives: Drug: XH-S003 Capsule

What is being measured

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

  1. UPCR

    The ratio to baseline of UPCR (sampled from 24-hour urine collection) on Day 90 after the first drug administration.

    Measured: Baseline and Day 90

Secondary outcomes (5)

  1. UACR

    The ratio to baseline of UACR on Day 90 after the first drug administration

    Measured: Baseline to Day 90

  2. UPE

    The ratio to baseline of UPE on Day 90 after the first drug administration

    Measured: Baseline to Day 90

  3. UAE

    The ratio to baseline of UAE on Day 90 after the first drug administration

    Measured: Baseline to Day 90

  4. eGFR

    eGFR change from baseline on Day 90 after the first drug administration.

    Measured: Baseline to Day 90

  5. Serum Creatinine

    Change from baseline of serum creatinine

    Measured: up to Day 90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2026
  2. Study start31 Dec 2024
  3. Primary completion23 Apr 2026
  4. Study completion23 Apr 2026

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
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07634744
Sponsor's protocol ID
XH-S003-IIa-101
Status last verified
Jun 2026
First submitted
27 Feb 2025
Last updated
25 Sep 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 XH-S003 Capsule in people with IgA Nephropathy, 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 13 inclusion and 27 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: finished, as of the sponsor's last update on 25 Sep 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

UPCR (time frame: Baseline and Day 90). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07634744.

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 25 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in