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El ensayo clínico NCT07498673 para Nefropatía primaria por IgA está aún no recluta. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí.
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A Study of YKST02 in Participants With Primary IgA Nephropathy Fase I temprana 12

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El ensayo clínico NCT07498673 está diseñado para estudiar el tratamiento de Nefropatía primaria por IgA. Este es un estudio intervencionista de Fase I temprana. Su estado actual es: aún no recluta. Se prevé iniciar el reclutamiento el 31 de marzo de 2026 hasta completar 12 participantes. Dirigido por Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, se espera que finalice el 30 de junio de 2027. Los datos se actualizaron por última vez en ClinicalTrials.gov el 27 de marzo de 2026.
Resumen

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 beh...
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Descripción detallada
This is a single-center, open-label, dose-escalation clinical trial designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary efficacy of YKST02 in adults with primary IgA nephropathy (IgAN).

Eligible participants are adults with IgAN and persistent proteinuria despite standard-of-care treatment.

The study consists of a screening period, a treatment...

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Título oficial

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of YKST02 in Participants With Primary IgA Nephropathy

Condiciones médicas
Nefropatía primaria por IgA
Otros ID del estudio
  • YKST02-N01
Número del NCT
NCT07498673
Inicio del estudio (real)
2026-03-31
Última actualización
2026-03-27
Fecha de finalización (estimada)
2027-06-30
Inscripción (prevista)
12
Tipo de estudio
Intervencionista
FASE
Fase I temprana
Estado general
Aún no recluta
Objetivo principal
Tratamiento
Método de asignación
N/A
Modelo de intervención
Diseño secuencial
Enmascaramiento
Ninguno (Abierto)
Brazos / Intervenciones
Grupo de participantesIntervención/Tratamiento
ExperimentalYKST02
Participants receive YKST02 administered by intravenous infusion in this single-arm, open-label, dose-escalation study. Participants receive an initial dosing phase followed by subsequent administrations at escalating dose levels. Dose levels and dosing schedules may be adjusted based on safety, tolerability, and pharmacokinetic/pharmacodynamic (PK/PD) data. A follow-up period is included for safety and efficacy asse...Mostrar más
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.
Resultado primario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Safety will be assessed by the incidence and severity of adverse events (AEs) and serious adverse events (SAEs).
From first dose through Week 25
Change from Baseline in UPCR
Efficacy will be evaluated by the change from baseline in urine protein-to-creatinine ratio (UPCR).
From baseline through Week 25
Change from Baseline in eGFR
Efficacy will be evaluated by the change from baseline in estimated glomerular filtration rate (eGFR).
From baseline through Week 25
Change from Baseline in Urinary Red Blood Cells
Efficacy will be evaluated by the change from baseline in urinary red blood cells.
From baseline through Week 25
Resultado secundario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
Area Under the Concentration-Time Curve (AUC) of YKST02
Area under the concentration-time curve (AUC), including AUC0-t and AUC0-∞, of YKST02 will be evaluated.
From first dose through Week 25
Maximum Observed Concentration (Cmax) of YKST02
Maximum observed plasma concentration (Cmax) of YKST02 will be evaluated.
From first dose through Week 25
Half-life (t1/2) of YKST02
Terminal elimination half-life (t1/2) of YKST02 will be evaluated.
From first dose through Week 25
Change from Baseline in Gd-IgA1
Pharmacodynamic effects will be evaluated by the change from baseline in galactose-deficient IgA1 (Gd-IgA1).
From baseline through Week 24.
Change from Baseline in Serum Immunoglobulin Levels
Changes from baseline in serum immunoglobulin levels will be assessed, including IgA, IgG, and IgM.
From baseline through Week 24
Change from Baseline in Complement Levels
Changes from baseline in complement levels will be assessed, including complement components C3 and C4.
From baseline through Week 24
Immunogenicity of YKST02
Immunogenicity will be assessed by the incidence of anti-drug antibodies (ADAs). Neutralizing antibodies (NAbs) will be evaluated in participants who are ADA-positive.
From baseline through Week 25
Changes in Lymphocyte Subsets
Changes from baseline in peripheral blood lymphocyte subsets will be assessed, including B cell subsets and T cell subsets.
From baseline through Week 24
Changes in Lymphocyte Activation Markers
Changes from baseline in activation status of lymphocyte populations will be assessed using relevant activation markers, as applicable.
From baseline through Week 24
Changes in Cytokine Levels
Changes from baseline in cytokine levels relevant to immune and inflammatory responses will be assessed.
From baseline through Week 24
Asistente de participación
Criterios de elegibilidad

Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Todos
  • 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
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology logoUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology
Parte responsable del estudio
Qiubai Li, Investigador principal, Professor and Chief Physician, Head of Rheumatology Department, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Contactos centrales del estudio
Contacto: Qiubai Li, MD, PhD, +86-27-85726338, [email protected]
1 Centros del estudio en 1 países

Hubei

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, 430022, China
Qiubai Li, MD, PhD, Contacto, +86-027-85726338, [email protected]
Qiubai Li, MD, PhD, Investigador principal