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Clinical Trials List

Protocol NumberCHK02-02
NCT Number(ClinicalTrials.gov Identfier)NCT05852938

2023-12-01 - 2029-06-30

Phase III

Not yet recruiting8

ICD-10N05.0

Unspecified nephritic syndrome with minor glomerular abnormality

ICD-10N05.1

Unspecified nephritic syndrome with focal and segmental glomerular lesions

ICD-10N05.6

Unspecified nephritic syndrome with dense deposit disease

ICD-10N05.7

Unspecified nephritic syndrome with diffuse crescentic glomerulonephritis

ICD-10N05.8

Unspecified nephritic syndrome with other morphologic changes

ICD-10N06.0

Isolated proteinuria with minor glomerular abnormality

ICD-10N06.1

Isolated proteinuria with focal and segmental glomerular lesions

ICD-10N06.6

Isolated proteinuria with dense deposit disease

ICD-10N06.7

Isolated proteinuria with diffuse crescentic glomerulonephritis

ICD-10N06.8

Isolated proteinuria with other morphologic lesion

ICD-10N07.0

Hereditary nephropathy, not elsewhere classified with minor glomerular abnormality

ICD-10N07.1

Hereditary nephropathy, not elsewhere classified with focal and segmental glomerular lesions

ICD-10N07.6

Hereditary nephropathy, not elsewhere classified with dense deposit disease

ICD-10N07.7

Hereditary nephropathy, not elsewhere classified with diffuse crescentic glomerulonephritis

ICD-10N07.8

Hereditary nephropathy, not elsewhere classified with other morphologic lesions

ICD-10N14.0

Analgesic nephropathy

ICD-10N14.1

Nephropathy induced by other drugs, medicaments and biological substances

ICD-10N14.2

Nephropathy induced by unspecified drug, medicament or biological substance

ICD-10N14.3

Nephropathy induced by heavy metals

ICD-10N14.4

Toxic nephropathy, not elsewhere classified

ICD-10N15.0

Balkan nephropathy

ICD-10N15.8

Other specified renal tubulo-interstitial diseases

ICD-9583.89

Nephritis and nephropathy, not specified as acute or chronic, with other specified pathological lesion in kidney

A Phase 3, Randomized, Double-blind, Placebo-controlled Study of BION-1301 in Adults with IgA Nephropathy (The BEYOND Study)

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator 徐邦治 Division of Nephrology
Hualien Tzu Chi Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Chien-Hsing Wu Division of Nephrology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Heng-Chih Pan Division of Nephrology
Chang Gung Medical Foundation Chang Gung Memorial Hospital, Keelung

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 吳家麟 Division of Nephrology
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator VIN-CENT Wu Division of Nephrology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 楊忠煒 Division of Nephrology
National Taiwan University Hospital Hsin-Chu Branch

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Chung-Yi Cheng Division of Nephrology
Taipei WanFang Hospital (Managed by Taipei Medical Univeristy)

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Junne-Ming Sung Division of Nephrology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Condition/Disease

IgA Nephropathy

Objectives

CHK02-02 is a Phase 3, randomized, double-blind, placebo-controlled trial in adult patients with primary immunoglobulin nephropathy type A (IgAN) who are at risk for progressive loss of kidney function. Randomization was based on region (Asia vs. all other regions), baseline proteinuria (? 2 g per day vs. < 2 g per day), and eGFR (? 45 mL/min/1.73m2 vs. & ;gt; 45 mL/min/1.73m2) for stratification. Approximately 272 subjects with eGFR ? 30 mL/min/1.73m2 at screening were randomly assigned in a 1:1 ratio to receive BION-1301 600 mg every 2 weeks (Q2W) or matching placebo for 104 weeks. . A maximum of 20 subjects with eGFR ? 20 and < 30 mL/min/1.73m2 will be included in the exploratory cohort, which will not be included in the primary or secondary analyses. The primary objective evaluates the effect of BION-1301 compared to placebo on proteinuria in adults with immunoglobulin A (IgA) nephropathy, and the key secondary objective evaluates the effect of BION-1301 compared to placebo on estimated glomerular filtration rate (eGFR), with a secondary objective assessing the impact of BION-1301 compared to placebo in Effects on specific clinical composite indicators during the trial.

Test Drug

BION-1301

Active Ingredient

BION-1301

Dosage Form

Subcutaneous injection

Dosage

150 mg/mL

Endpoints

Evaluating the effect of BION-1301 compared with placebo on proteinuria in adults with immunoglobulin A (IgA) nephropathy

Inclution Criteria

-Male and female subjects aged ≥ 18 years at the time of signing the informed consent form (ICF) prior to initiation of any study specific activities/procedures.
-Biopsy-proven IgAN diagnosed within the past 10 years prior to Screening, that, in the opinion of the Investigator, is not due to secondary causes. A pseudonymized copy of the report must be available for review by the Sponsor or designee prior to randomization. If biopsy report within 10 years is not available, re-biopsy may be permitted upon discussion with the Medical Monitor.
-eGFR ≥ 30 mL/min/1.73m^2 at Screening based on the 2021 CKD-EPI equation.
-Total urine protein ≥ 1.0 g/day and UPCR ≥ 0.7 g/g (700 mg/g), as measured from an adequate 24-hour urine collection at Screening by a central laboratory.
-Stable on a maximally tolerated dose of ACEi/ARB for at least 12 weeks prior to Screening unless intolerant to ACEi/ARB. May also be on a stable and well tolerated dose of SGLT2i and/or ERAs/MRAs for at least 12 weeks prior to Screening for the treatment of IgAN. Subjects are expected to stay on the ACEi/ARB, SGLT2i and/or the ERAs/MRAs for the duration of the study.
-Body mass index (BMI) between 18 and 40 kg/m^2.
-Screening weight of 45 to 150 kg.
-Men and women of childbearing potential (WOCBP; per Clinical Trials Facilitation and Coordination Group [CTFG] 2020) must agree to follow protocol-specified contraception guidance from Screening through approximately 5 half-lives (24 weeks) after the final dose of study drug. Use of hormonal contraceptive agents must have been initiated > 1 month prior to first dose of study drug.
-Provide written informed consent and be willing to comply with study visits and procedures.

Exclusion Criteria

-Secondary forms of IgAN as determined by the Investigator, in the setting of systemic disorders, infections, autoimmune disorders or neoplasias.
-Diagnosis of IgA Vasculitis.
-Current or history of nephrotic syndrome.
-Average blood pressure > 150/90 mm Hg (systolic/diastolic) from 3 readings obtained at the initial Screening visit. If blood pressure is too high, the 3 readings may be repeated once within the Screening period if clinically appropriate as per the Investigator.
-Clinical suspicion of IgAN with rapidly progressive glomerulonephritis (RPGN) based on KDIGO guidelines
-Chronic Kidney Disease, either clinically suspected or based on biopsy, resulting from any condition or another glomerulopathy/podocytopathy other than IgAN.
-History of Type 1 Diabetes.
-Subjects with Type 2 diabetes are excluded if any of the following are present:

-Screening HbA1c (glycated hemoglobin) of > 8%.
-Evidence of diabetic changes on kidney biopsy, performed for any reason.
-History of diabetic microvascular disease (retinopathy, neuropathy, nephropathy) and/or macrovascular disease (atherosclerotic heart disease, peripheral vascular disease, cerebrovascular disease).
-Unstable anti-diabetic regimen:
-Prior exposure to any antibody directed against APRIL.
-History of a previous severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis, including a history of allergy or hypersensitivity to any component of BION-1301, or history of severe hypersensitivity reaction to any monoclonal antibody.
-Received an investigational new drug within 28 days or 5 half-lives, whichever is longer, prior to Screening.
-Received systemic corticosteroid therapy including budesonide (Tarpeyo/Kinpeygo) for > 14 days within 12 weeks prior to Screening.
-Use of systemic immunosuppressant medications.
-Any confirmed or suspected immunosuppressive or immune-deficient state, including but not limited to common variable immunodeficiency (CVID), HIV infection or asplenia, history of bone marrow or organ transplantation with exception of corneal transplants.
-Current severe infection requiring antimicrobials or history of recurrent, severe, infections as determined by the Investigator.
-Positive serology test for hepatitis A virus IgM antibodies (anti-HAV IgM), hepatitis B surface antigen (HBsAg), detectable hepatitis B virus (HBV) DNA, hepatitis C virus (HCV) antibodies (subjects who completed treatment and are persistently antibody be allowed), or antibodies to HIV-1 and/or HIV-2 at Screening.
-Received a live vaccination within 12 weeks prior to Screening or plan to have a live vaccination within 6 months after the last dose of study drug.
-History of malignancy unless cancer free for at least 5 years or non-melanoma skin cancer that was completely resected. A subject with curatively treated cervical carcinoma in situ is eligible for the study. Subjects with low-risk prostate cancer (i.e., Gleason score < 7 and prostate specific antigen < 10 ng/mL) are allowed.
-Pregnancy or breastfeeding or intent to become pregnant or to donate sperm during the study period and until 24 weeks after last dose.
-History or evidence of any other clinically significant disorder, condition, disease, or laboratory finding that, in the Investigator's assessment, would place the subject at unacceptable risk, limit compliance with study requirements, or confound interpretation of study results.
-IgG levels < 6 g/L at Screening.
-Participation in another interventional trial with an investigational agent/device is prohibited during the course of this study.

The Estimated Number of Participants

  • Taiwan

    14 participants

  • Global

    292 participants

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