IgA Nephropathy (IgAN)
Conditions
Brief summary
IgA nephropathy (IgAN) is a chronic progressive kidney disease, and long-term control of proteinuria and prevention of relapse are crucial for delaying disease progression. Patients with IgAN who achieve proteinuria remission after receiving Nefecon for 9 months or longer still face the risk of proteinuria relapse after treatment discontinuation. This study is to evaluate the efficacy and safety of Nefecon 8 mg treatment for 15 months as a maintenance therapy to reduce the risk of IgAN relapse in proteinuria-remitted patients.
Interventions
DRUGNEFECON
NEFECON 8mg once daily by mouth for 15 months
DRUGPlacebo
Placebo oral capsule once daily by mouth for 15 months
Sponsors
Nanfang Hospital, Southern Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed primary IgAN with biopsy verification; * Female or male participants ≥18 years of age; * Completion of ≥9 months of Nefecon 16 mg QD at the baseline visit; * Proteinuria ≥ 1g/d prior to initiation of Nefecon; * Proteinuria\<0.5 g/day (or UPCR \<0.5 g/g) at screening and randomization visit; * eGFR ≥30 ml/min/1.73m² at screening; * On stable treatment with supportive treatment (including RAASi, SGLT2i, ERA) for at least 1 month prior to the baseline visit;
Exclusion criteria
* Systemic diseases that may cause mesangial immunoglobulin A deposition, including but not limited to IgA vasculitis nephritis, systemic lupus erythematosus, dermatitis herpetiformis, ankylosing spondylitis, and others; * Type 1 or type 2 diabetes mellitus; * Presence of primary or secondary glomerulopathies (e.g., membranous nephropathy, focal segmental glomerulosclerosis, C3 glomerulopathy and others); * Active infection, severe hepatic impairment (Child-Pugh Class C), congestive heart failure, and malignant tumor within the past 5 years; * On current or planned dialysis or kidney transplantation; * Participants who have been treated with systemic glucocorticoids and immunosuppressive agents within the past 3 months, including mycophenolate mofetil, hydroxychloroquine, cyclophosphamide, azathioprine, leflunomide, calcineurin inhibitors, and Chinese traditional medicines with immunosuppressive effects (such as Tripterygium wilfordii, Sinomenium acutum, Tripterygium Glycosides Tablets, Kunxian Capsules, Kunming Shanhaitang Tablets, etc.); treatment with B-cell targeted biological agents (such as telitacicept and sibeprenlimab, etc.); complement pathway inhibitors, etc.; * Poorly controlled hypertension (resting systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg); * Participants taking potent inhibitors of cytochrome P450 (CYP) 3A4 within the past 1 month, such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin, or cyclosporine; * Females who are pregnant, breastfeeding, or planning to become pregnant in the trial period. * Any other conditions that, in the investigator's judgment, make the patient ineligible for this clinical study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to first composite disease relapse | 15 months | either a ≥100% increase in UPCR and an absolute UPCR ≥0.5 g/g, or a ≥30% decline in eGFR from randomization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| eGFR slope | 15 months | eGFR slope from baseline to Month 15 |
| The proportion of patients with UPCR ≥0.5 g/g | 15 months | The proportion of patients with sustained UPCR ≥0.5 g/g |
| The proportion of patients with UPCR ≥1 g/g | 15 months | The proportion of patients with sustained UPCR ≥1 g/g |
| Changes in UPCR and 24-hour urinary protein | 3, 6, 9, 12, and 15 Months | Changes in UPCR and 24-hour urinary protein from baseline to Months 3, 6, 9, 12, and 15 |
| Major adverse kidney events | 15 months | The proportion of patients with the first occurrence of major adverse kidney events within 15 months, defined as the occurrence of any one of the following: eGFR ≤15 ml/min/1.73m², maintenance dialysis, kidney transplantation, ≥30% decrease in eGFR, or kidney-related death |
| All-cause mortality | 15 months | All-cause mortality |
Countries
China
Contacts
CONTACTFan Fan Hou
Outcome results
None listed