PMR-EC-1207
Research type
Research Study
Full title
A Phase II, Parallel Group, Randomized, Multicentre, Open Label Study to Compare the Pharmacokinetics of Tacrolimus in De Novo Pediatric Allograft Recipients Treated with an Advagraf or Prograf Based Immunosuppressive Regimen, Including a Long-Term Follow-Up
IRAS ID
81802
Contact name
Stephen Marks
Contact email
Sponsor organisation
ICON plc
Eudract number
2011-000078-80
Duration of Study in the UK
3 years, 9 months, 0 days
Research summary
Patients who are receiving an organ transplant will need to take special drugs to prevent their transplanted organ from being rejected. This can be a combination of drugs that will reduce the activity of the immune system (the bodies own natural defence), which will help prevent the body from attacking the donor organ.
Tacrolimus is a drug which has been used to treat both adult and child patients in the prevention of liver, kidney and heart rejection for more than 13 years under the trade name Prograf®. There are currently a number of formulations of Tacrolimus on the market, such as Prograf and Advagraf with the difference being in how the drug is formulated. Prograf is a twice daily capsule formulation and Advagraf is a once daily capsule formulation, both taken orally. Advagraf is approved for the prevention of adult kidney or liver transplant rejection, but not currently approved for the use in patients who are children.
This study was designed to compare the way a child’s body processes and uses Advagraf versus Prograf. This is called pharmacokinetics or PK for short. This study will last for 1 year and be performed in children undergoing primary heart, kidney or liver transplantation. The PK data will be collected after their first dose of Tacrolimus and following repeated administration across a four week period. After the 4 week period, they will remain in the study for 48 weeks, so that they can be monitored to assess how safe and effective Advagraf is in comparison to Prograf over a longer period of time.
Patients and their families will formally agree to participate in this study by signing informed consent (parent/guardian) and informed assent (children). Patients and their parents/guardians will be free to withdraw participation from this study at any given time.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
11/NW/0659
Date of REC Opinion
8 Dec 2011
REC opinion
Further Information Favourable Opinion