Ignite Creation Date:
2024-05-05 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00373165
Status:
COMPLETED
Last Update Posted:
2006-09-13
First Post:
2006-09-05
Brief Title:
Prophylaxis With Ganciclovir Improves Graft Survival in Renal Allograft Recipients
Sponsor:
Lower Saxony Center for Nephrology
Organization:
Lower Saxony Center for Nephrology
Study Overview
Official Title:
Open Randomised Study Comparing Preemptive Therapy With Intravenous Ganciclovir With and Without Additional Oral Ganciclovir for CMV Prophylaxis in Immunosuppressed Renal Transplant Patients Receiving Monitoring of CMV Viral Load
Status:
COMPLETED
Status Verified Date:
2006-09
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:
Study Phase IV
Study Type Open-label multicenter randomised clinical trial with two arms stratified for an intensified immunosuppressive regimen in patients at high risk for acute rejection
Study Description 148 kidney transplant recipients at risk for CMV disease were randomized and treated with ganciclovir capsules for 3 months Group A prophylaxis N74 or received ganciclovir IV only in case of proven CMV viral load Group B preemptive therapy N74 Initially a 2 months follow up was planned in this trial However the study group decided to offer a longterm follow up to all patients and amended the protocol respectively
The aim of the study was to identify the most efficacious way to prevent renal transplant recipients from CMV disease and to find out if one of these two strategies may increase graft or patient survival Therefore both wellknown approaches of CMV prevention were compared in two study groups
Prophylaxis Group A Oral primary prophylaxis with ganciclovir capsules was started directly after transplantation and performed until day 90 In case of CMV infection proven CMV viral load or symptomatic CMV disease treatment with ganciclovir IV was initiated
Preemptive Therapy Group B No oral primary prophylaxis was given Treatment with ganciclovir IV was given to patients with proven CMV viral load CMV infection or CMV disease only
Study Type Open-label multicenter randomised clinical trial with two arms stratified for an intensified immunosuppressive regimen in patients at high risk for acute rejection
Study Description 148 kidney transplant recipients at risk for CMV disease were randomized and treated with ganciclovir capsules for 3 months Group A prophylaxis N74 or received ganciclovir IV only in case of proven CMV viral load Group B preemptive therapy N74 Initially a 2 months follow up was planned in this trial However the study group decided to offer a longterm follow up to all patients and amended the protocol respectively
The aim of the study was to identify the most efficacious way to prevent renal transplant recipients from CMV disease and to find out if one of these two strategies may increase graft or patient survival Therefore both wellknown approaches of CMV prevention were compared in two study groups
Prophylaxis Group A Oral primary prophylaxis with ganciclovir capsules was started directly after transplantation and performed until day 90 In case of CMV infection proven CMV viral load or symptomatic CMV disease treatment with ganciclovir IV was initiated
Preemptive Therapy Group B No oral primary prophylaxis was given Treatment with ganciclovir IV was given to patients with proven CMV viral load CMV infection or CMV disease only
Detailed Description:
Disease Background More than 60 of adult people are asymptomatically infected with cytomegalovirus CMV Due to immunosuppressive therapy renal graft recipients are at risk for CMV infection and life-threatening disease CMV can cause a variety of symptoms in the immunocompromised host including CMV retinitis pneumonia or colitis After grafting CMV disease most commonly occurs in the transplanted organ and can trigger graft dysfunction and acute rejection Therefore prophylaxis or preemptive therapy should be used in order to prevent graft recipients from CMV disease
CMV prophylaxis means the administration of antiviral agents to all patients at risk for CMV disease directly after transplantation ie for 3 months Prophylaxis is in particular used for patients at high risk for CMV disease
CMV preemptive therapy or targeted prophylaxis means CMV monitoring and initiation of induction therapy with antiviral agents in patients with proven CMV viral load only CMV infection This prevents non-infected patients from being exposed to antiviral drugs and the related side effects like neutropenia or renal toxicity Preemptive therapy is in particular used for patients at lower or moderate risk for CMV disease
Study Description 148 kidney transplant recipients at risk for CMV disease were randomized and treated with ganciclovir capsules for 3 months Group A prophylaxis N74 or received ganciclovir IV only in case of proven CMV viral load Group B preemptive therapy N74 Initially a 2 months follow up was planned in this trial However the study group decided to offer a longterm follow up to all patients and amended the protocol respectively
The aim of the study was to identify the most efficacious way to prevent renal transplant recipients from CMV disease and to find out if one of these two strategies may increase graft or patient survival Therefore both wellknown approaches of CMV prevention were compared in two study groups
Prophylaxis Group A Oral primary prophylaxis with ganciclovir capsules was started directly after transplantation and performed until day 90 In case of CMV infection proven CMV viral load or symptomatic CMV disease treatment with ganciclovir IV was initiated
Preemptive Therapy Group B No oral primary prophylaxis was given Treatment with ganciclovir IV was given to patients with proven CMV viral load CMV infection or CMV disease only
CMV prophylaxis means the administration of antiviral agents to all patients at risk for CMV disease directly after transplantation ie for 3 months Prophylaxis is in particular used for patients at high risk for CMV disease
CMV preemptive therapy or targeted prophylaxis means CMV monitoring and initiation of induction therapy with antiviral agents in patients with proven CMV viral load only CMV infection This prevents non-infected patients from being exposed to antiviral drugs and the related side effects like neutropenia or renal toxicity Preemptive therapy is in particular used for patients at lower or moderate risk for CMV disease
Study Description 148 kidney transplant recipients at risk for CMV disease were randomized and treated with ganciclovir capsules for 3 months Group A prophylaxis N74 or received ganciclovir IV only in case of proven CMV viral load Group B preemptive therapy N74 Initially a 2 months follow up was planned in this trial However the study group decided to offer a longterm follow up to all patients and amended the protocol respectively
The aim of the study was to identify the most efficacious way to prevent renal transplant recipients from CMV disease and to find out if one of these two strategies may increase graft or patient survival Therefore both wellknown approaches of CMV prevention were compared in two study groups
Prophylaxis Group A Oral primary prophylaxis with ganciclovir capsules was started directly after transplantation and performed until day 90 In case of CMV infection proven CMV viral load or symptomatic CMV disease treatment with ganciclovir IV was initiated
Preemptive Therapy Group B No oral primary prophylaxis was given Treatment with ganciclovir IV was given to patients with proven CMV viral load CMV infection or CMV disease only
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