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Clinical Trials List

Protocol NumberVT-001-0050
NCT Number(ClinicalTrials.gov Identfier)NCT04716231
Active

2023-11-01 - 2027-12-31

Phase II/III

Not yet recruiting5

Recruiting1

ICD-10N05.9

Unspecified nephritic syndrome with unspecified morphologic changes

ICD-9583.0

Nephritis and nephropathy, not specified as acute or chronic, with lesion of proliferative glomerulonephritis

A Phase 2b/3, Multi-part, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Atacicept in Subjects with IgA Nephropathy (IgAN)

  • Trial Applicant

    MEDPACE TAIWAN LIMITED

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Yi wen chiu 無
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator
Kaohsiung Municipal Ta-Tung Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Ping-Chin Lai 無
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 彭渝森 無
Far Eastern Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator CHENG-HSU CHEN 無
Taichung Veterans General Hospital

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 、Berger Disease

Objectives

To determine the effect of Atacicept on proteinuria and maintenance of renal function in subjects with IgAN

Test Drug

Atacicept

Active Ingredient

Atacicept

Dosage Form

Solution for Injection

Dosage

Each prefilled syringe contains 1.0 mL of VT-001 150 mg/mL Injection

Endpoints

Evaluating the effect of atacicept compared with placebo on changes in proteinuria in adult subjects with IgAN

Inclution Criteria

Key Inclusion Criteria:

Must have the ability to understand and sign a written informed consent form
Male or female of ≥18 years of age
Total urine protein excretion ≥1.0 g per 24-hour or urine protein to creatinine ratio (UPCR) ≥1.0 mg/mg based on a 24-hour urine sample during the Screening Period
Diagnosis of IgAN as demonstrated by renal biopsy conducted within 10 years
eGFR ≥ 30 mL/min/1.73 m2, as per the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
On a stable prescribed regimen of RAASi for at least 12 weeks that is at the maximum labeled or tolerated dose at Screening
Systolic blood pressure ≤150 mmHg and diastolic blood pressure ≤90 mmHg

Exclusion Criteria

Key Exclusion Criteria:

IgAN secondary to another condition (e.g., liver cirrhosis), or other causes of mesangial IgA deposition including IgA vasculitis (i.e., Henoch-Schonlein purpura), systemic lupus erythematosus (SLE), dermatitis herpetiformis, ankylosing spondylitis
Total urine protein excretion ≥ 5g per 24-hour or urine protein to creatinine ratio (UPCR) ≥ 5 mg/mg based on a 24-hour urine sample during the Screening Period
Evidence of rapidly progressive glomerulonephritis (loss of ≥ 50% of eGFR within 3 months of screening)
Evidence of nephrotic syndrome within 6 months of screening (serum albumin <30g/L in association with UPCR >3.5 mg/mg
Renal or other organ transplantation prior to, or expected during the study
Concomitant chronic renal disease in addition to IgAN
Uncontrolled diabetes, defined as hemoglobin-A1c (HbA1c) >7.5% at screening
History of tuberculosis (TB), untreated latent TB infection (LTBI), or evidence of active TB determined by a positive Quantiferon test
Participation in the Phase 2b (Parts A and B) study or any previous treatment with atacicept

The Estimated Number of Participants

  • Taiwan

    15 participants

  • Global

    376 participants

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