Otsuka Voclosporin PASS
Research type
Research Study
Full title
An observational post-authorisation safety study (PASS) in Europe to further characterise and quantify long-term safety profile with respect to neurotoxicity, chronic nephrotoxicity, and malignancy with use of voclosporin
IRAS ID
334920
Contact name
Ravindra Rajakariar
Contact email
Sponsor organisation
Otsuka Pharmaceutical Netherlands B.V
Clinicaltrials.gov Identifier
EUPAS1000000284, ENCePP
Duration of Study in the UK
5 years, 7 months, 30 days
Research summary
Lupus nephritis (LN) is a serious complication of systemic lupus erythematosus (SLE), characterised by deposition of immune complexes in affected tissues, including the kidney. Around 10%-30% of those with LN will develop kidney failure requiring dialysis or kidney transplant, the presence of which has been associated with a 26-fold increase in mortality risk compared with a general population.
The current treatment approach for LN includes high dose of corticosteroids plus immunosuppressants. Voclosporin is a novel Calcineurin inhibitor immunosuppressant. In the EU, voclosporin is indicated for the treatment of adult patients with active LN. This study will evaluate the long-term risks with use of voclosporin in LN patients in the real-world setting when used in accordance with the approved EU Summary of Product Characteristics (SmPC) by assessing the incidence of the following safety events: neurotoxicity, chronic nephrotoxicity, and any malignancy.
This study is a multicentre, prospective, observational cohort study to assess the long-term safety of voclosporin in LN patients in Europe. The prospective study design with primary data collection enables collecting granular data on exposures, outcomes, and other variables, as available.
Adult patients with active LN, who initiated voclosporin in accordance with the EU SmPC and are able to provide an informed consent will be included in the study.
The study period is anticipated as 6-years which consists of an expected 4-year
enrolment period, and a minimum of 2-year observation period for each patient enrolled.
The study period starts at the time of enrolment of the first patient into the study (second quarter 2024) and ends when the observation period of the last enrolled patient is completed (anticipated in Q2 2030).REC name
West of Scotland REC 4
REC reference
24/WS/0143
Date of REC Opinion
2 Oct 2024
REC opinion
Favourable Opinion