Efficacy and Safety of Nefecon on Prevention of Relapse of IgA Nephropathy (NeFRIN)

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

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.

Study Overview

• Status: 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

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Recruiting
      • Nanfang Hospital, Southern Medical University
      • Contact: 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 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.

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 composite disease relapse	either a ≥100% increase in UPCR and an absolute UPCR ≥0.5 g/g, or a ≥30% decline in eGFR from randomization	15 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
eGFR slope	eGFR slope from baseline to Month 15	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
The proportion of patients with UPCR ≥0.5 g/g	The proportion of patients with sustained UPCR ≥0.5 g/g	15 months
The proportion of patients with UPCR ≥1 g/g	The proportion of patients with sustained UPCR ≥1 g/g	15 months
All-cause mortality	All-cause mortality	15 months

Collaborators and Investigators

• Sponsor: Nanfang Hospital, Southern Medical University

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 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): September 2, 2026
• Last Update Submitted That Met QC Criteria: August 30, 2026
• Last Verified: August 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