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Clinical Trials List

Protocol NumberAUR-VCS-2020-04

NCT Number(ClinicalTrials.gov Identfier)NCT05962788

Completed

2023-12-13 - 2027-03-30

Phase III

Recruiting3

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

An Open-Label Extension Study to Assess the Long-Term Safety and Efficacy 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 無

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator KUO-WEI YEH 無

Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yuan-Yow Chiou

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Adolescent Lupus Nephritis

Objectives

The VOCAL-EXT trial (AUR-VCS-2020-04) is an extension of the VOCAL trial (AUR-VCS-2020-03). The purpose of the VOCAL-EXT trial is to provide you with additional voclosporin treatment to your standard of care. This trial aims to investigate the safety and efficacy (how well the drug works) in children or adolescents over an additional 12-month period, for a total trial period of 18 months from the start of VOCAL. All subjects who have completed 24 weeks of treatment with the investigational drug (voclosporin or placebo) in the VOCAL (AUR-VCS-2020-03) trial and continue to meet all trial requirements will be eligible to consent to this extension trial, up to approximately forty (40) children and adolescents (12 years and older). Approximately 6 subjects are expected to be recruited in Taiwan. The expected number of subjects per country is estimated based on the overall number of countries/trial facilities in the trial. However, as this is a competitive recruitment process, the progress of the trial may vary from country to country/institution to institution, and the actual number of participants in Taiwan and each institution may differ and is not limited to the number listed in this informed consent form.

Test Drug

softgel capsule

Active Ingredient

Voclosporin

Dosage Form

softgel capsule

Dosage

7.9 mg/capsule

Endpoints

Following completion of treatment in adolescent subjects with lupus nephritis (LN) in the AUR-VCS-2020-03 trial (VOCAL), up to 12 months of additional treatment will be administered to evaluate the long-term safety and tolerability of voclosporin.

Inclution Criteria

Inclusion Criteria:

Written informed consent from parent/guardian before any study-specific procedures are performed, if applicable per local regulations.
Age-appropriate assent or informed consent from subject before any study-specific procedures are performed.
Subjects who have completed 24 weeks of treatment with study drug (voclosporin/placebo) in the VOCAL study. Subjects who had a temporary interruption and were able to successfully re-start study drug will be allowed to enroll after Medical Monitor approval.
In the opinion of the Investigator subject requires continued immunosuppressive therapy.
Subject is willing to continue to take oral MMF for the duration of the study.

Exclusion Criteria

Exclusion Criteria:

Currently taking or known need for any of the following medications during the study:

Cholestyramine or other drugs that may interfere with enterohepatic recirculation of MMF
Calcineurin inhibitors (CNIs) (e.g., cyclosporin and tacrolimus)
Strong CYP3A4/5 inhibitors and inducers (e.g., ketoconazole, rifampin, itraconazole, clarithromycin)
Currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected to require dialysis during the study period.
A planned kidney transplant within study treatment period.
Subjects with any medical condition which in the Investigator's judgement may be associated with increased risk to the subject or may interfere with study assessments or outcomes

The Estimated Number of Participants

Taiwan

6 participants
Global

40 participants