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Clinical Trials List

Protocol NumberAUR-VCS-2020-04

NCT Number(ClinicalTrials.gov Identfier)NCT05962788

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

2025/11/11

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

VOCAL-EXT 試驗 (AUR-VCS-2020-04) 是 VOCAL 試驗 (AUR-VCS-2020-03) 的延伸。VOCAL-EXT 試驗的目的是為了提供您在標準治療中附加 voclosporin 治療。本試驗旨在調查經過額外 12 個月期間在兒童或青少年的安全性和療效（藥物的作用效果有多好），從 VOCAL 開始總計給予 18 個月試驗期。已經完成在 VOCAL (AUR-VCS-2020-03) 試驗的 24 週試驗藥物（voclosporin 或安慰劑）治療，並且繼續符合所有試驗要求的所有受試者將符合資格可表示同意參加此延伸試驗，最多大約四十 (40) 位兒童和青少年（12 歲以上）。台灣預計招募約 6 名受試者。每個國家預計的受試者人數依據試驗中整體國家/試驗機構數量進行估計。不過，由於這是一個競爭性的試驗招募，每個國家/試驗機構的試驗進度可能不同，台灣和每個試驗機構的實際受試者人數可能不同，且不限定於本知情同意書中所列的人數。

Test Drug

Voclosporin

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