YKST02 for adults with primary IgA nephropathy.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Long-term safety and tolerability of HRS-5965 in primary IgA nephropathy

  This study tests whether HRS-5965 capsules are safe to use over the long term and whether they can reduce 24-hour urinary protein and slow eGFR decline in adults with primary IgA nephropathy who previously completed or stopped during maintenance.

  Recruiting Phase 2 Chengdu Suncadia Medicine Co., Ltd. · Beijing, Beijing Municipality · NCT07582133

• SHR-2173 for people with primary IgA nephropathy

  This trial will test whether SHR-2173 injections can reduce proteinuria and protect kidney function in adults with primary IgA nephropathy compared with placebo over 48 weeks.

  Recruiting at 2 sites Phase 2 Guangdong Hengrui Pharmaceutical Co., Ltd · Guangzhou, Guangdong and 1 other locations · NCT07354932

• Tonsil removal plus immunosuppression for high-risk IgA nephropathy in Caucasian adults

  This trial will see if removing the tonsils combined with immunosuppressive medicine helps Caucasian adults with high-risk IgA nephropathy preserve kidney function and reduce proteinuria.

  Recruiting at 2 sites St. Petersburg State Pavlov Medical University · Saint Petersburg and 1 other locations · NCT07074951

• HRS-5965 capsule for primary IgA nephropathy

  This Phase 3 trial will test whether HRS-5965 capsules reduce proteinuria and are safe for people with biopsy-confirmed primary IgA nephropathy who have persistent proteinuria and eGFR ≥30.

  Recruiting Phase 3 Chengdu Suncadia Medicine Co., Ltd. · Beijing, Beijing Municipality · NCT07014826

• Long-term safety evaluation of iptacopan for patients with primary IgA nephropathy

  This study is testing the long-term safety of a drug called iptacopan for people with primary IgA nephropathy who have already participated in earlier trials.

  Recruiting Phase 3 Novartis · Glendale, Arizona and 160 other locations · NCT04557462

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.