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

NCT07604311 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 288

Last updated 2026-05-22

No results posted yet for this study

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)

Interventions

DRUG

NEFECON

NEFECON 8mg once daily by mouth for 15 months

DRUG

Placebo

Placebo oral capsule once daily by mouth for 15 months

Sponsors & Collaborators

  • Nanfang Hospital, Southern Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2028-12-01
Completion
2028-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07604311 on ClinicalTrials.gov