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RECRUITING
NCT07822100
NA

To Assess the Efficacy and Safety of Utilizing Galactose-deficient IgA1 Biomarker Changes to Guide Pathogenic IgA-targeted Therapeutic Strategies

Sponsor: Hong Zhang

View on ClinicalTrials.gov

Summary

The goal of this open-label, randomized study is to evaluate the efficacy and safety of the personalized treatment model in which Gd-IgA1 is dynamically monitored to guide medication adjustment in progressive IgAN patients treated with Nefecon or telitacicept. Researchers will compare two groups of participants: those who have Gd-IgA1 checked regularly during treatment, and those who do not. This is to find out if regular Gd-IgA1 checks can help doctors adjust medication better and get better treatment results.

Official title: Development and Validation of a Gd-IgA1 Guided Precision Therapy System for Targeted Therapeutic Strategies of IgA Nephropathy: An Open-label, Random Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

374

Start Date

2026-08-24

Completion Date

2028-02

Last Updated

2026-09-16

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Gd-IgA1 monitoring

Participants in the experimental group will undergo a total of five Gd-IgA1 tests at baseline and during the follow-up period, and their clinicians will use these results to guide medication adjustment.

Locations (1)

Peking University First Hospital

Beijing, Beijing Municipality, China