Pediatric Kidney Transplant- Valcyte- CMV prophylaxis
Research type
Research Study
Full title
Tolerability of up to 200 Days of Valganciclovir Oral Solution or Tablets in Pediatric Kidney Transplant Recipients
IRAS ID
76600
Contact name
David Milford
Sponsor organisation
F. Hoffmann-La Roche Ltd.
Eudract number
2010-022514-47
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
N/A
Research summary
Cytomegalovirus (CMV) is a common virus related to the cold sore virus and chicken pox virus, and it infects people of all ages. CMV may cause serious infection in people who have a weakened immune system after an organ transplant and can be prevented if appropriate medication is given after the transplant.In many parts of the world Valcyte is licensed to be used for up to 200 days (6 months) in adults who have had a kidney transplant and who are at a high chance of getting CMV infection. In the United States this medicine is also licensed to be used for up to 100 days (3 months) in children aged 4 months to 16 years who have had either a heart or kidney transplant. In a previous study in children involving treatment of up to 100 days, the signs of CMV infection were not obvious until the end of this period, which suggests that extending treatment would be beneficial.This study is non-comparative, meaning all participants will be receiving Valcyte. No placebo or alternative medications are being used. The study is intended to find out if prolonged treatment with Valcyte for up to 200 days (as performed in adults) can be safely tolerated in children and if this prevents CMV infection.Valcyte is administered as a liquid or tablet once daily by mouth. Trial subjects will be expected to attend monthly clinic visits, though these will be mainly consistent with normal after transplant follow up care.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
11/EM/0211
Date of REC Opinion
5 Sep 2011
REC opinion
Further Information Favourable Opinion