A Study of YKST02 in Participants With Primary IgA Nephropathy
Condition(s) studied
Investigational drug(s) / intervention(s)
YKST02: YKST02 is an investigational drug administered by intravenous infusion. It is provided as a sterile formulation for clinical use. Dosing may vary based on study design and ongoing evaluation of safety, tolerability, and pharmacokinetic/pharmacodynamic (PK/PD) data.
Study summary
The goal of this clinical trial is to evaluate the safety and tolerability of YKST02 and to explore its potential to treat adults with primary IgA nephropathy (IgAN). The study will also assess how the drug moves through the body and how it affects the immune system.
The main questions it aims to answer are:
* Is YKST02 safe and well tolerated?
* Does YKST02 reduce protein levels in the urine?
* How does YKST02 behave in the body (pharmacokinetics, PK)?
* How does YKST02 affect the immune system (pharmacodynamics, PD)? Participants are adults with IgAN who have persistent proteinuria despite standard treatment.
Participants will:
* Receive YKST02 by intravenous (IV) infusion
* Be monitored after each dose for safety
* Attend clinic visits for safety assessments and laboratory tests
* Provide blood and urine samples during the study and follow-up period
Eligibility
Primary outcome measure(s)
- Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) — From first dose through Week 25
Safety will be assessed by the incidence and severity of adverse events (AEs) and serious adverse events (SAEs). - Change from Baseline in UPCR — From baseline through Week 25
Efficacy will be evaluated by the change from baseline in urine protein-to-creatinine ratio (UPCR). - Change from Baseline in eGFR — From baseline through Week 25
Efficacy will be evaluated by the change from baseline in estimated glomerular filtration rate (eGFR). - Change from Baseline in Urinary Red Blood Cells — From baseline through Week 25
Efficacy will be evaluated by the change from baseline in urinary red blood cells.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | Recruiting |
More Union Hospital, Tongji Medical College, Huazhong University of Science and Technology trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07498673 on ClinicalTrials.gov ↗ ← All trials in China