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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000284
• EU PAS number:
  EUPAS1000000284
• Study ID:
  1000000284
• Official title and acronym:
  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
• DARWIN EU® study:
  No
• Study countries:
  Czechia

  Italy

  Netherlands

  Poland

  Spain

  Sweden

  United Kingdom
• Study description:
  This PASS will evaluate the long-term risks with use of voclosporin in lupus nephritis (LN) patients treated with voclosporin in the real-world setting in Europe, as per the approved Summary of Product Characteristics (SmPC), by assessing the incidence of the following safety events: neurotoxicity, chronic nephrotoxicity, and any malignancy.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Otsuka Pharmaceutical Netherlands B.V.

Study timelines

Date when funding contract was signed

Planned: 21/05/2024

Actual: 18/07/2024

Study start date

Planned: 31/01/2025

Actual: 03/02/2025

Date of final study report

Planned: 31/12/2030

Sources of funding

Pharmaceutical company and other private sector 

Study protocol

Initial protocol

348-201-0021_Voclo-PA_Final_08Aug2023_approved.pdf

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)

Other study registration identification numbers and links

348-201-00021