IgA Nephropathy
Conditions
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
Interventions
DRUGXH-S003 Capsule
Oral， once daily
Sponsors
S-INFINITY Pharmaceuticals Co., Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
It's a open lable study。
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects must meet the following inclusion criteria: ● Male and female patients aged ≥18 years with a renal biopsy-confirmed diagnosis of primary IgA nephropathy: 1. For patients with eGFR (CKD-EPI) ≥ 45 mL/min/1.73m2 at screening, a renal pathology biopsy within 10 years confirmed primary IgA nephropathy; 2. 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; 3. Renal pathology biopsy shows tubulointerstitial fibrosis \< 50%; 4. Renal pathology biopsy shows crescent formation in \< 50% of glomeruli; 5. 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).
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| UPCR | Baseline and Day 90 | The ratio to baseline of UPCR (sampled from 24-hour urine collection) on Day 90 after the first drug administration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| UACR | Baseline to Day 90 | The ratio to baseline of UACR on Day 90 after the first drug administration |
| UPE | Baseline to Day 90 | The ratio to baseline of UPE on Day 90 after the first drug administration |
| UAE | Baseline to Day 90 | The ratio to baseline of UAE on Day 90 after the first drug administration |
| eGFR | Baseline to Day 90 | eGFR change from baseline on Day 90 after the first drug administration. |
| Serum Creatinine | up to Day 90 | Change from baseline of serum creatinine |
Countries
China
Outcome results
None listed