Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 for prevention of proteinuria relapse in proteinuria-remitted patients.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator | Placebo |
|
| Treatment arm | Experimental | NEFECON |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NEFECON | Drug | NEFECON 8mg once daily by mouth for 15 months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first occurrence of proteinuria relapse | ≥100% increase in UPCR and UPCR ≥0.5 g/g, separated by at least 1 week | 15 months |
| Measure | Description | Time Frame |
|---|---|---|
| eGFR slope | eGFR slope from baseline to Month 15 | 15 months |
| The proportion of patients with UPCR ≥0.5 g/g | The proportion of patients with UPCR ≥0.5 g/g within 15 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fan Fan Hou | Contact | +8620 61641591 | ffhouguangzhou@163.com |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005922 | Glomerulonephritis, IGA |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Drug |
Placebo oral capsule once daily by mouth for 15 months |
|
| 15 months |
| The proportion of patients with UPCR ≥1 g/g | The proportion of patients with UPCR ≥1 g/g within 15 months | 15 months |
| Changes in UPCR and 24-hour urinary protein | Changes in UPCR and 24-hour urinary protein from baseline to Months 3, 6, 9, 12, and 15 | 3, 6, 9, 12, and 15 Months |
| Major adverse kidney events | 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 | 15 months |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |