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New treatment option for Primary IgA Nephropathy
Official title A Study of YKST02 in Participants With Primary IgA Nephropathy
ClinicalTrials.gov ID: NCT07498673
What this study is testing
What is YKST02?
YKST02 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for primary iga nephropathy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- Able to understand the study procedures and provide written informed consent
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuhan, Hubei, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.