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

NCT07604311 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: NFEC-2026-268
• Study Type: interventional
• Target: 288
• Locations: 0 countries
• Sites: N/A

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 for prevention of proteinuria relapse in proteinuria-remitted patients.

Conditions

IgA Nephropathy (IgAN)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• eGFR slope

  15 months

• The proportion of patients with UPCR ≥0.5 g/g

  15 months

• The proportion of patients with UPCR ≥1 g/g

  15 months

• Changes in UPCR and 24-hour urinary protein

  3, 6, 9, 12, and 15 Months

• Major adverse kidney events

  15 months

Study Arms (2)

Control

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Treatment arm

EXPERIMENTAL

NEFECON

Drug: NEFECON

Interventions

NEFECON DRUG

NEFECON 8mg once daily by mouth for 15 months

Treatment arm

Placebo DRUG

Placebo oral capsule once daily by mouth for 15 months

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

MeSH Terms

Conditions

Glomerulonephritis, IGA

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Fan Fan Hou

CONTACT

+8620 61641591; ffhouguangzhou@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: May 22, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share