Shire SHP602-206 Study to Monitor for the Development of Renal Tumours
Research type
Research Study
Full title
A Multicentre Study to Monitor for the Potential Development of Renal Tumours in Subjects with Transfusional Iron Overload who were Previously Exposed to Deferitazole
IRAS ID
167163
Contact name
John Porter
Contact email
Sponsor organisation
Shire Development LLC
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
This is a multi-national, multicentre study that will provide monitoring for the possible development of renal tumours in subjects who participated in previous clinical studies with deferitazole, and who were administered the study drug for more than 3 days. This investigation has been suggested by the Sponsor after a 2 year rat study in to the long-term effects of deferitazole found an increase in the amount of cancerous and non-cancerous renal tumours in the rats.
Study subjects who are confirmed eligible and have consented will be able to enrol and participate for a maximum of 7 visits over a period of up to 5 years. All visits will involve a renal ultrasound, which can be followed up with an MRI in the event of any unclear or suggestive ultrasound results. Ultrasound examination will occur at 6 months and 12 months, and then annually for the duration of the study.
Study-emergent adverse events limited to confirmed renal tumours (non-cancerous or cancerous) and study procedure related events will be collected at each study visit. In addition, information on all concomitant medications will be collected. No investigational product will be administered during the course of this study.REC name
London - Riverside Research Ethics Committee
REC reference
15/LO/0349
Date of REC Opinion
9 Apr 2015
REC opinion
Further Information Favourable Opinion