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Clinical Trials List

Protocol NumberAUR-VCS-2020-03
NCT Number(ClinicalTrials.gov Identfier)NCT05288855
Completed

2022-04-01 - 2025-09-30

Phase III

Terminated3

ICD-10E10.21

Type 1 diabetes mellitus with diabetic nephropathy

ICD-10E11.21

Type 2 diabetes mellitus with diabetic nephropathy

ICD-10N16

Renal tubulo-interstitial disorders in diseases classified elsewhere

ICD-9583.81

Nephritis and nephropathy, not specified as acute or chronic, in diseases classified elsewhere

A Double-Blind, Placebo-Controlled, Dose Escalation Study to Assess the Efficacy, Safety and Pharmacokinetics of Voclosporin in Adolescent and Pediatric Subjects With Lupus Nephritis

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/03/01

Investigators and Locations

Principal Investigator I-JUNG TSAI Division of Pediatrics
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator KUO-WEI YEH Division of Pediatrics
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Yuan-Yow Chiou
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Condition/Disease

Adolescent Lupus Nephritis

Objectives

The goal of this trial is to investigate whether voclosporin, in addition to standard treatment, can reduce disease activity over a 24-week treatment period, determine its safety, and the optimal dose for treating lupus nephritis in children or adolescents.

Test Drug

軟膠囊劑

Active Ingredient

Voclosporin

Dosage Form

132

Dosage

7.9 mg

Endpoints

• For adolescents with active LN, efficacy assessment of renal response after 24 weeks of voclosporin treatment compared to placebo.

Inclution Criteria

Key Inclusion Criteria:

Previous diagnosis of systemic lupus erythematosus (SLE) as per the 2019 EULAR/ ACR classification criteria.
Subjects with kidney biopsy confirmed active lupus nephritis.

Exclusion Criteria

Exclusion Criteria:

Estimated glomerular filtration rate (eGFR) <60 mL/minute/1.73 m2 at screening.
Current or medical history of:

Congenital or acquired immunodeficiency.
Clinically significant drug or alcohol abuse prior to screening.
Malignant neoplasm.
Lymphoproliferative disease or previous total lymphoid irradiation.
Known severe viral infections within 3 months of screening; or known human immunodeficiency virus infection, or hepatitis B or C virus infection at any time prior to screening.
Active tuberculosis (TB) or known history of TB/evidence of old TB if not taking prophylaxis with isoniazid.
Currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected to require dialysis during the study period.
Other known clinically significant active medical conditions, for which the condition or the treatment of the condition may affect the study assessments or outcomes.
Currently taking or known need for any of the following medications:

Immunosuppression biologic agents within 12 weeks prior to randomization, cyclophosphamide, calcineurin inhibitors (CNIs) and live attenuated vaccines, initiation or dose change of ACE inhibitors/ARBs within 4 weeks prior to randomization, IV corticosteroids and IV immunoglobulin within 2 weeks prior to screening, strong CYP3A4/5 inhibitors and inducers within 2 weeks prior to randomization.

The Estimated Number of Participants

  • Taiwan

    6 participants

  • Global

    40 participants

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