A Phase IIa Study in Primary IgA Nephropathy Patients

NCT07634744 | Completed Phase 2

• 1 other identifier: XH-S003-IIa-101
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

IgA Nephropathy

Outcome Measures

Primary Outcomes (1)

• UPCR

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

  Baseline and Day 90

Secondary Outcomes (5)

• UACR

  Baseline to Day 90

• UPE

  Baseline to Day 90

• UAE

  Baseline to Day 90

• eGFR

  Baseline to Day 90

• Serum Creatinine

  up to Day 90

Study Arms (1)

XH-S003 Capsule

EXPERIMENTAL

100mg and 25mg XH-S003 capsules QD Oral.

Drug: XH-S003 Capsule

Interventions

XH-S003 Capsule DRUG

Oral， once daily

XH-S003 Capsule

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ● 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;
• 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).

You may not qualify if:

• 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);
• 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);

Sponsors & Collaborators

• S-INFINITY Pharmaceuticals Co., Ltd: lead

Study Sites (1)

Peking University First Hospital

Beijing, China

Location

MeSH Terms

Conditions

Glomerulonephritis, IGA

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: It's a open lable study。
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: June 9, 2026
• Study Start: December 31, 2024
• Primary Completion: April 23, 2026
• Study Completion: April 23, 2026
• Last Updated: June 9, 2026

Record last verified: 2026-06

Locations

CN (1)