Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00140543
Status:
COMPLETED
Last Update Posted:
2021-08-23
First Post:
2005-08-31
Brief Title:
European Trial of Immunosuppression in SPK Tx
Sponsor:
EUROSPK Study Group
Organization:
EUROSPK Study Group
Study Overview
Official Title:
A European Multicenter Open-Label Randomised Trial to Evaluate the Efficacy and Safety of Sirolimus and Tacrolimus Compared to MMF and Tacrolimus With Short-Course Induction Therapy Short-Term Steroids Application in de Novo SPK Transplanted Diabetic Patients
Status:
COMPLETED
Status Verified Date:
2021-08
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:
1 To determine and compare the efficacy of TacrolimusRapa versus TacrolimusMMF-based immunosuppression in conjunction with initial short-term steroids and polyclonal antibody administration in Type 1-diabetic patients undergoing simultaneous pancreaskidney allograft transplantation
2 To evaluate the safety of TacrolimusRapa versus TacrolimusMMF in terms of drug-related complications and overimmunosuppression-associated complications particularly under monitoring of the pharmacokinetic profile of all drugs administered
2 To evaluate the safety of TacrolimusRapa versus TacrolimusMMF in terms of drug-related complications and overimmunosuppression-associated complications particularly under monitoring of the pharmacokinetic profile of all drugs administered
Detailed Description:
This will be a controlled randomised study to be performed in 15-20 pancreas transplantation centers throughout Europe Patients will be randomised into one of two treatment groups Group 1 will receive Tacrolimus and Mycophenolate Mofetil best group in EuroSPK001 trial Group 2 will receive Tacrolimus and Sirolimus Both groups will receive in association short-term corticosteroids and polyclonal antibody preparation Patients will be randomly assigned to one of the 2 treatment groups in a 11 ratio before transplantation The study will last 3 years with a first interim analysis of the data at 6 months and a complete analysis at 1 year
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