Actively Recruiting
A Study of YKST02 in Participants With Primary IgA Nephropathy
Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2026-05-12
12
Participants Needed
1
Research Sites
60 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
A Study of YKST02 in Participants With Primary IgA Nephropathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of primary IgA nephropathy (IgAN)
- Proteinuria above a set threshold at screening
- Receiving stable standard-of-care therapy for IgAN for an adequate duration unless contraindicated or not tolerated
- Women of childbearing potential must have a negative pregnancy test prior to study drug administration and agree to use effective contraception
- Male participants must agree to use effective contraception
- Able to understand the study procedures and provide written informed consent
You will not qualify if you...
- Secondary IgA nephropathy linked to other diseases like liver disease, autoimmune disorders, or infections
- Other significant kidney diseases unrelated to IgAN such as diabetic nephropathy, lupus nephritis, or vasculitis
- Nephrotic syndrome unsuitable for study participation
- Rapidly progressive glomerulonephritis or rapidly declining kidney function
- Estimated glomerular filtration rate (eGFR) below 45 mL/min/1.73 m²
- Immunodeficiency or low immunoglobulin G (IgG) levels
- Clinically significant abnormal lab tests including blood, liver, or clotting problems
- Need for systemic corticosteroids for other conditions
- Use of immunosuppressive, targeted, or biologic therapies recently or planned during the study
- Prior treatment with B-cell-depleting or other targeted biologic therapies recently
- History of demyelinating disorders like multiple sclerosis
- Significant cardiovascular or cerebrovascular disease within 6 months before screening
- History of organ transplant or planned transplant during the study
- Current or planned dialysis during the study
- Major surgery within 4 weeks before screening or planned during the study
- Active infections needing systemic treatment, recent serious infections, or chronic infections
- Known active hepatitis B, hepatitis C, or HIV infection
- Active or untreated latent tuberculosis
- History of spleen removal
- Uncontrolled health conditions such as poorly controlled high blood pressure or diabetes
- Cancer within the past 5 years except treated non-invasive cancers
- Known allergy to YKST02 or its components
- Use of another investigational product within 4 weeks or 5 half-lives prior to screening
- Use or planned use of live or attenuated vaccines within 4 weeks prior to screening or during the study
- Any condition making the participant unsuitable for the study according to the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
Actively Recruiting
Research Team
Q
Qiubai Li, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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