A Study of YKST02 in Participants With Primary IgA Nephropathy

NCT07498673 | Not Yet Recruiting Early Phase 1

• 1 other identifier: YKST02-N01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Primary IgA Nephropathy

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (10)

• Area Under the Concentration-Time Curve (AUC) of YKST02

  From first dose through Week 25

• Maximum Observed Concentration (Cmax) of YKST02

  From first dose through Week 25

• Half-life (t1/2) of YKST02

  From first dose through Week 25

• Change from Baseline in Gd-IgA1

  From baseline through Week 24.

• Change from Baseline in Serum Immunoglobulin Levels

  From baseline through Week 24

Other Outcomes (2)

• Changes in Renal Histopathology

  From baseline through Week 24

• Changes in Immune-Related Biomarkers

  From baseline through Week 24

Study Arms (1)

YKST02

EXPERIMENTAL

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 assessments.

Drug: YKST02

Interventions

YKST02 DRUG

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.

YKST02

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 participants must agree to use effective contraception
• Able to understand the study procedures and provide written informed consent

You may not qualify 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
• 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

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

Study Sites (1)

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

Location

MeSH Terms

Conditions

Glomerulonephritis, IGA

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Qiubai Li, MD, PhD

CONTACT

+86-27-85726338; qiubaili@hust.edu.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chief Physician, Head of Rheumatology Department

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: March 27, 2026
• Study Start: March 31, 2026
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

CN (1)