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| Name | Class |
|---|---|
| Roche Pharma AG | INDUSTRY |
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This study is an open, randomised trial in which one group of patients (control) will receive the golden standard therapy and the other group (treatment) will receive individually adapted immunosuppression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | individual adapted immunosuppression |
|
| 2 | Active Comparator | golden standard therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| individual adapted immunosuppression | Drug | individual adapted immunosuppression |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Graft function as measured by Cr EDTA AUC | at 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Graft survival | at 1 year | |
| Patient survival | at 1 year | |
| Graft function measured by estimated GFR (eGFR) (MDRD and Cockroft-Gault) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raymond Vanholder, MD, PhD | University Hospital, Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Ghent | Ghent | 9000 | Belgium |
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| Label | URL |
|---|---|
| website of the University Hospital Ghent | View source |
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| golden standard therapy |
| Drug |
golden standard therapy |
|
| at 1 year |
| Frequency of biopsy proven acute rejection episodes | at 1 year |
| Incidence of biopsy proven acute rejection (BPAR) and clinical (non-biopsy proven) acute rejection episodes treated by a full course anti-rejection therapy (e.g. steroids) (Treatment of rejection according to center practice). | at 1 year |
| Incidence of rejection treated by antibodies (OKT3, ATG) | at 1 year |
| Time to first rejection (days) | at 1 year |
| Severity of rejection as assessed by BANFF 2005 score | at 1 year |
| Number of acute rejections per patient | at 1 year |
| Plasma creatinine and eGFR | at month 1, 3 and yearly (2 and 3 years) |
| Measured GFR | at month 3 and yearly |
| Proteinuria | at month 1, 3 and at 1 and 3 years |
| Incidence and score of borderline changes and acute rejection | in month 3 and month 12 biopsy |
| Incidence and score of chronic alloimmune injury/rejection and nonimmune injury | in month 3 and month 12 biopsies (BANFF 2005) |
| Development and evolution of glucose abnormalities | at 1 year |
| blood pressure | at 1 year |
| ambulatory 24-hr blood pressure monitoring | at 1 year and 3 years |
| Left ventricular mass assessed by echocardiography | at 1 year and 3 years |
| Fasting lipid profile | at baseline, month 1,3,6 and yearly |
| CMV infection (as measured with whole blood PCR) and disease | at 1 year |
| Polyoma virus replication as measured by whole blood PCR | at 1 year |
| Incidence of BK nephritis | in month 3 and month 12 biopsies |
| Incidence of PTLD and Nonmelanoma skin cancer | at 1 year and yearly |
| Incidence of EBV reactivation (as measured with whole blood PCR) | at 1 year and yearly |