Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00169910
Status:
COMPLETED
Last Update Posted:
2012-12-17
First Post:
2005-09-09
Brief Title:
VIP Vascular Imaging Project Study on the Progression of Cardiovascular Disease in Renal Transplant Recipients
Sponsor:
Leiden University Medical Center
Organization:
Leiden University Medical Center
Study Overview
Official Title:
VIP Vascular Imaging Project Prospective Randomized Study on the Effect of AUC-monitored Treatment With Steroids Combined With Either a Calcineurin Inhibitor or Mycophenolate Mofetil on the Progression of Subclinical Cardiovascular Disease in Renal Transplant Recipients
Status:
COMPLETED
Status Verified Date:
2012-12
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:
This is a prospective randomized study to compare the influence of area under the curve AUC-monitored dual treatment with steroids in combination with either a calcineurin inhibitor CNI or mycophenolate mofetil MMF on the progression of subclinical cardiovascular disease in renal transplant recipients
Since CNI have a detrimental effect on cardiovascular risk factors it is the researchers hypothesis that renal recipients after CNI withdrawal will have more reduction of markers of cardiovascular disease
Since CNI have a detrimental effect on cardiovascular risk factors it is the researchers hypothesis that renal recipients after CNI withdrawal will have more reduction of markers of cardiovascular disease
Detailed Description:
Stable renal transplant patients on maintenance immunosuppressive therapy with steroids a calcineurin inhibitor CNI and mycophenolate mofetil MMF will be randomized for AUC-monitored withdrawal of either CNI or MMF
The progression of cardiovascular markers will be assessed by yearly measurements of Intima Media Thickness Pulse Wave Velocity and Left Ventricular Hypertrophy in both groups
The duration of the study will be 3 years and the target sample size is 100 patients per arm
The progression of cardiovascular markers will be assessed by yearly measurements of Intima Media Thickness Pulse Wave Velocity and Left Ventricular Hypertrophy in both groups
The duration of the study will be 3 years and the target sample size is 100 patients per arm
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