Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00336817
Status:
COMPLETED
Last Update Posted:
2017-03-09
First Post:
2006-06-12
Brief Title:
A Prospective Study on the Tolerability and Efficacy of the de Novo Use of Myfortic in Liver Transplant Recipients
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
A Prospective Study on the Tolerability and Efficacy of the de Novo Use of Myfortic in Liver Transplant Recipients
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study is to compare the safety and efficacy of Myfortic with CellCept in liver transplant patients Myfortic and CellCept are both immunosuppressive anti-rejection drugs CellCept is commonly used after liver transplantation but gastrointestinal GI side effects are very common sometimes necessitating in its discontinuation Myfortic is a new drug similar to CellCept except it is enteric-coated Our hypothesis is that Myfortic has less GI side effects than CellCept and also has comparable effectiveness to CellCept
Detailed Description:
This is a prospective randomized double-blinded single center safety and efficacy study comparing Myfortic with CellCept used after liver transplantation Patients with biopsy-proven acute cellular rejection renal insufficiency ie acute or chronic renal failure requiring hemodialysis or patients with creatinine clearance 50 mlmin or calcineurin inhibitor-induced neurotoxicity defined as the presence of neurologic symptoms such as tremors altered mental status seizures etc will be randomized to start on either Myfortic 720 mg po bid or CellCept 1 gm po bid In those patients with calcineurin-induced neurotoxicity or nephrotoxicity tacrolimus or cyclosporine doses will also be reduced to maintain serum trough levels of 4-8 mgdl or 100-200 mgdl respectively
Comparison Thirty patients will be enrolled and randomized in this two-armed double-blinded study- half of the patients will receive Myfortic and the other half CellCept
Comparison Thirty patients will be enrolled and randomized in this two-armed double-blinded study- half of the patients will receive Myfortic and the other half CellCept
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None