Abstract: SA-PO0662
Efficacy and Safety of Nefecon on Prevention of Relapse of IgAN (NEFRIN): Study Design of a Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial
Session Information
- Glomerular Diseases: Clinical, Outcomes, and Therapeutics Research - Other
October 24, 2026 | Location: Exhibit Hall A, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Glomerular Diseases
- 1402 Glomerular Diseases: Clinical, Outcomes, and Therapeutics
Authors
- Nie, Sheng, Southern Medical University Nanfang Hospital, Guangzhou, Guangdong, China
- Xie, Di, Southern Medical University Nanfang Hospital, Guangzhou, Guangdong, China
- Zhou, Shiyu, Southern Medical University Nanfang Hospital, Guangzhou, Guangdong, China
- Qin, Xianhui, Southern Medical University Nanfang Hospital, Guangzhou, Guangdong, China
- Xu, Xin, Southern Medical University Nanfang Hospital, Guangzhou, Guangdong, China
- Hou, Fan Fan, Southern Medical University Nanfang Hospital, Guangzhou, Guangdong, China
Background
Nefecon (targeted-release budesonide) is designed to deliver budesonide directly to the distal ileum, targeting mucosal immune pathways for treatment of IgA nephropathy (IgAN). NeflgArd study has demonstrated that 9-month treatment with Nefecon significantly reduced the level of urine protein-to-creatinine ratio (UPCR) in adults with IgAN. However, proteinuria relapse and renal function deterioration after immunosuppressive agents withdrawal is common in clinical practice. The hypothesis of NEFRIN study is that long-term and low-dose Nefecon treatment may reduce the risk of IgAN relapse.
Methods
NEFRIN is a multicenter, randomized, double-blind, placebo-controlled study, which will be conducted at 15 centers in China. The trial plans to enroll 288 adults with biopsy-confirmed IgAN who have received Nefecon 16 mg/day for ≥9 months and achieved disease remission (defined as urinary protein excretion <0.5 g/day or UPCR <0.5 g/g on two consecutive assessments ≥1 week apart). Eligible participants are those with an eGFR ≥30 mL/min/1.73 m^2 and on stable supportive care for ≥1 month before randomization. Following a 2-week run-in (Nefecon 8 mg/day) period, participants will be randomly assigned to receive Nefecon 8 mg/day or placebo at 1:1 ratio for 15 months, in addition to supportive care at the investigators' discretion. The primary measurement is time to first composite disease relapse, defined as either a ≥100% increase in UPCR and an absolute UPCR ≥0.5 g/g, or a ≥30% decline in eGFR from randomization. Secondary endpoints include eGFR slope, the proportions of participants with UPCR ≥0.5 g/g and ≥1.0 g/g, changes in UPCR and urinary protein excretion rate, major adverse kidney events, as well as all-cause mortality.
Results
Recruitment is planned to begin in 2026 Q3, and the final participant visit is expected in 2028 Q3.
Conclusion
This trial investigates whether long-term maintenance of Nefecon following initial remission can prevent IgAN relapse in patients with IgAN. It will provide an evidence for maintenance management of IgAN to improve long-term outcome of disease.
Funding
- Commercial Support – Everestmedicines Co., LTd