PMR-EC-1206
Research type
Research Study
Full title
A Phase II, Open-Label, Multi-Center Study to Compare the Pharmacokinetics of Tacrolimus in Stable Pediatric Allograft Recipients Converted from a Prograf® Based Immunosuppressive Regimen to a Tacrolimus Prolonged Release, Advagraf® Based Immunosuppressive Regimen, Including a Long-Term Follow Up
IRAS ID
70602
Contact name
Stephen Marks
Contact email
Sponsor organisation
ICON plc
Eudract number
2010-020925-42
Duration of Study in the UK
4 years, 9 months, 0 days
Research summary
Research Summary:
Tacrolimus is a drug, which prevents organ rejection following a transplant. There are two capsule formulations of tacrolimus; Prograf® is a twice daily formulation and Advagraf® is a once daily formulation. Both of these products are widely marketed but currently Advagraf® is only being marketed for adults.
This clinical trial uses Advagraf® in children (between 5 years and 16 years of age) who underwent a single organ transplant within 6-months of consenting into this study and are currently stable being treated with Prograf®. This study has been designed to collect information on how a child's body absorbs, distributes, metabolizes, and eliminates (this is known as pharmakokinetic or PK data) Advagraf® compared to Prograf®. The study will also assess how safe and effective Advagraf® is when given to children over a longer period of time.
This study is going to be performed at a single site in the UK, Royal Manchester Children's Hospital, which is a specialist regional centre for kidney transplants. In total, it is intended that 11 European centers will be recruited into the study.
On entering the study, all patients will already be receiving Prograf®. All patients will undergo a 30-day screening period, following which they will switch from twice daily commercial Prograf® to twice daily Prograf® as a study medication. The dose of Prograf® will remain unchanged. After one week of receiving Prograf® as a study medication, all patients will switch to once daily Advagraf® treatment. All patients will then continue receiving Advagraf® for the remainder of the study.
The information obtained in this study may help improve treatment of child transplant patients.
Lay summary of study results:
Prograf and Advagraf are different forms of medicine containing tacrolimus (the same active ingredient), which help prevent organ rejection after a transplant. Prograf is taken twice a day and Advagraf is taken once a day. Children and teenagers who had liver, kidney or other transplants could take part. In this study they took Prograf for 7 days, then switched to Advagraf. The amount of tacrolimus in the bloodstream in 24 hours was similar for Prograf and Advagraf. 2 participants showed signs of transplant rejection by the body. The biopsy from 1 transplant confirmed rejection and was considered to be moderate. There were 3 transplant failures. 1 failure was due to a kidney transplant rejection. The other 2 failures were due to participants leaving the study early, so this information was not available (1 heart transplant and 1 liver transplant). However, all transplants of participants who completed the study continued to work well, and all transplants and participants survived during the study. There were no new safety concerns from long-term use of Advagraf in children and teenagers.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
11/H1002/1
Date of REC Opinion
8 Mar 2011
REC opinion
Further Information Favourable Opinion