YKST02 for adults with primary IgA nephropathy.
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of YKST02 in Participants With Primary IgA Nephropathy
This trial will test whether intravenous YKST02 is safe and can reduce urine protein in adults with primary IgA nephropathy who have persistent proteinuria despite standard treatment.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Academic / other |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT07498673 on ClinicalTrials.gov |
What this trial studies
This is a single-center, open-label, dose-escalation trial giving YKST02 by intravenous infusion to adults with primary IgA nephropathy and persistent proteinuria despite standard-of-care. Participants are closely monitored for safety after each dose and attend scheduled clinic visits for laboratory tests and clinical assessments. The study will collect blood and urine for pharmacokinetic, pharmacodynamic, biomarker, and immunogenicity analyses and may adjust dose levels based on emerging safety data. Preliminary efficacy is explored by tracking changes in proteinuria and other kidney-related clinical measures.
Who should consider this trial
Good fit: Adults with a confirmed diagnosis of primary IgA nephropathy who have protocol-defined persistent proteinuria despite receiving stable standard-of-care therapy and who meet the study's safety and contraceptive requirements are the intended participants.
Not a fit: People with secondary forms of IgA nephropathy, other significant non-IgAN renal diseases, rapidly progressive kidney decline, or conditions that make IV biologic treatment unsafe are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, YKST02 could lower proteinuria and potentially slow progression of kidney damage in people with primary IgA nephropathy.
How similar studies have performed: Some immune-targeting and complement-directed therapies for IgA nephropathy have shown promising early results, but this specific agent is experimental and prior human data are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of primary IgA nephropathy (IgAN) * Proteinuria above a protocol-defined threshold at screening * Receiving stable standard-of-care therapy for IgAN for an adequate duration prior to enrollment, 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 Exclusion Criteria: * Secondary IgA nephropathy (e.g., associated with liver disease, autoimmune disorders, infections, or other systemic conditions) * Other clinically significant renal diseases unrelated to IgAN (e.g., diabetic nephropathy, lupus nephritis, vasculitis) * Nephrotic syndrome considered unsuitable for study participation * Rapidly progressive glomerulonephritis or rapidly declining renal function * Estimated glomerular filtration rate (eGFR) \<45 mL/min/1.73 m² * Immunodeficiency or low immunoglobulin G (IgG) levels below normal * Clinically significant abnormal laboratory findings (e.g., hematologic, hepatic, or coagulation abnormalities) * Requirement for systemic corticosteroids for concomitant conditions * Use of immunosuppressive, targeted, or biologic therapies within a defined period prior to screening or anticipated use during the study * Prior treatment with B-cell-depleting or other targeted biologic therapies within a defined period * History of demyelinating disorders (e.g., multiple sclerosis) * Clinically significant cardiovascular or cerebrovascular disease within 6 months prior to screening * History of organ transplantation or planned transplantation during the study * Current dialysis or anticipated need for dialysis during the study * Major surgery within 4 weeks prior to screening or planned during the study * Active infection requiring systemic therapy, recent serious infection, or chronic/recurrent infections * Known active hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection * Active or untreated latent tuberculosis * History of splenectomy * Uncontrolled comorbidities (e.g., poorly controlled hypertension or diabetes) * Malignancy within the past 5 years, except adequately treated non-invasive cancers * Known hypersensitivity to YKST02 or its components * Receipt of another investigational product within 4 weeks or 5 half-lives (whichever is longer) prior to screening * Receipt of live or attenuated vaccines within 4 weeks prior to screening or planned during the study * Any condition that, in the investigator's judgment, would make the participant unsuitable for the study
Where this trial is running
Wuhan, Hubei
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
Study contacts
- Study coordinator: Qiubai Li, MD, PhD
- Email: qiubaili@hust.edu.cn
- Phone: +86-27-85726338
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.