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क्लिनिकल ट्रायल NCT07498673 के लिए प्राथमिक IgA नेफ्रोपैथी वर्तमान में अभी भर्ती शुरू नहीं है। सभी विवरणों के लिए क्लिनिकल ट्रायल रडार कार्ड दृश्य और AI खोज उपकरण देखें, या यहाँ कुछ भी पूछें।
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A Study of YKST02 in Participants With Primary IgA Nephropathy प्रारंभिक चरण I 12

अभी भर्ती शुरू नहीं
चिकित्सा परीक्षण का विवरण मुख्य रूप से अंग्रेजी में उपलब्ध है। हालाँकि, ट्रायल रडार AI मदद कर सकता है! बस 'अध्ययन समझाएं' पर क्लिक करें और अपनी चुनी हुई भाषा में परीक्षण की जानकारी देखें और चर्चा करें।
क्लिनिकल ट्रायल NCT07498673 का मुख्य उद्देश्य उपचार का अध्ययन करना है। यह चिकित्सकीय अध्ययन प्राथमिक IgA नेफ्रोपैथी से जुड़ा हुआ है और यह एक प्रारंभिक चरण I हस्तक्रियात्मक परीक्षण है। परीक्षण वर्तमान में अभी भर्ती शुरू नहीं चल रहा है। इसमें 12 प्रतिभागियों को शामिल करने की योजना है और प्रतिभागियों का नामांकन 31 मार्च 2026 से शुरू होगा। Union Hospital, Tongji Medical College, Huazhong University of Science and Technology इस परीक्षण का नेतृत्व कर रहे हैं और इसके 30 जून 2027 तक पूरा होने की उम्मीद है। ClinicalTrials.gov वेबसाइट पर यह जानकारी 27 मार्च 2026 को अंतिम बार अपडेट की गई थी।
संक्षिप्त सारांश

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...
और दिखाएँ
विस्तृत विवरण
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...

और दिखाएँ
आधिकारिक शीर्षक

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

स्वास्थ्य स्थितियां
प्राथमिक IgA नेफ्रोपैथी
अन्य अध्ययन आईडी
  • YKST02-N01
NCT नंबर
NCT07498673
अध्ययन प्रारंभ तिथि (वास्तविक)
2026-03-31
अंतिम अद्यतन प्रकाशित
2026-03-27
अध्ययन की समाप्ति तिथि (अनुमानित)
2027-06-30
नामांकन (अनुमानित)
12
अध्ययन प्रकार
हस्तक्रियात्मक
चरण
प्रारंभिक चरण I
स्थिति
अभी भर्ती शुरू नहीं
प्राथमिक उद्देश्य
उपचार
डिज़ाइन आवंटन
निर्दिष्ट नहीं
हस्तक्षेप मॉडल
अनुक्रमिक
अंधकरण
कोई नहीं (खुला लेबल)
समूह/हस्तक्षेप
प्रतिभागी समूह/शाखाहस्तक्षेप/उपचार
प्रयोगात्मकYKST02
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...और दिखाएँ
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.
प्राथमिक परिणाम माप
परिणाम मापमाप विवरणसमय सीमा
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
द्वितीयक परिणाम माप
परिणाम मापमाप विवरणसमय सीमा
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
भागीदारी सहायक
पात्रता मानदंड

अध्ययन के लिए पात्र आयु
वयस्क, वृद्ध वयस्क
अध्ययन के लिए न्यूनतम आयु
18 Years
अध्ययन के लिए पात्र लिंग
सभी
  • 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
अध्ययन उत्तरदायी पक्ष
Qiubai Li, मुख्य अन्वेषक, Professor and Chief Physician, Head of Rheumatology Department, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
अध्ययन केंद्रीय संपर्क
संपर्क: Qiubai Li, MD, PhD, +86-27-85726338, [email protected]
1 1 देशों में अध्ययन स्थान

Hubei

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