Efficacy and Safety of Nefecon on Prevention of Relapse of IgA Nephropathy: a Randomized, Double-blinded, Placebo-Controlled Trial (NeFRIN)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: IgA Nephropathy (IgAN)
• Intervention / Treatment: Drug: Placebo; Drug: NEFECON

• Study Type: Interventional
• Enrollment (Estimated): 288
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Fan Fan Hou; Phone Number: +8620 61641591; Email: ffhouguangzhou@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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
• 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 IgAVN, systemic lupus erythematosus, dermatitis herpetiformis, ankylosing spondylitis, and others;
• Presence of other glomerulopathies (e.g., C3 glomerulopathy, nephrotic syndrome and/or diabetes nephropathy), active infection, severe hepatic impairment (Child-Pugh Class C), congestive heart failure, and a history of 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, etc.); complement pathway inhibitors, etc.;
• Poorly controlled diabetes mellitus (HbA1c>8%）
• Poorly controlled hypertension （≥160/100mmHg）
• Participants taking potent inhibitors of cytochrome P450 (CYP) 3A4.
• Females who are pregnant, breastfeeding, or plan to become pregnant in the trial period.
• Any other conditions that, in the investigator's judgment, make the patient ineligible for this clinical study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control; Placebo	Drug: Placebo; Placebo oral capsule once daily by mouth for 15 months
Experimental: Treatment arm; NEFECON	Drug: NEFECON; NEFECON 8mg once daily by mouth for 15 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Nanfang Hospital, Southern Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: May 18, 2026
• First Submitted That Met QC Criteria: May 18, 2026
• First Posted (Actual): May 22, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Autoimmune Diseases; Immune System Diseases; Glomerulonephritis; Nephritis; Glomerulonephritis, IGA
• Other Study ID Numbers: NFEC-2026-268

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No