Calcineurin Inhibitor Based Immunosuppression Withdrawal
Status:
Completed
Trial end date:
2012-11-01
Target enrollment:
Participant gender:
Summary
Damage and scarring of a transplanted kidney has become the most common cause of loss of the
transplanted kidney. This kidney damage is a complex process caused by many factors including
injury during obtaining and transplanting the kidney, injury from the immune system, injury
from infections, and injury from drugs used to stop rejection. This injury leads to scars
that decrease the kidney's ability to function properly, and over time the kidney is lost.
Prograf® (tacrolimus) has been one of the main drugs used to prevent rejection. However, when
used over time it has been shown to cause chronic damage and scarring in the transplanted
kidney.
The purpose of this experimental study is to determine whether children can safely be
withdrawn from Prograf® after transplantation and changed to Rapamycin® (sirolimus). Recent
research studies in adult transplantation have demonstrated that with the use of Rapamycin®
(sirolimus), it is possible to discontinue the use of Prograf (tacrolimus) with no increase
in rejection, with decreased scarring in the kidney, and with improvements in kidney function
and survival of the kidney. A total of 50 children will enroll in this study at university
centers around the country. This study will last about 3 years.
Phase:
N/A
Details
Lead Sponsor:
Pediatric Nephrology of Alabama
Collaborators:
Pfizer The Emmes Company, LLC The EMMES Corporation