The purpose of this study is to focus on potential differences in the occurrence of new-onset Diabetes Mellitus (a glucose metabolism disorder) when two different regimens of immunosuppressive treatment are compared.
The primary objective of this study is to compare an Immunosuppressive regimen with 10 days of corticosteroids with a regimen with only an optional intra-op bolus of corticosteroids with regard to incidence of new onset Diabetes Mellitus as per the American Diabetic Association (ADA) criteria at any point up to 24 weeks after kidney transplantation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,166
Diagnosis of new onset Diabetes Mellitus as per ADA criteria at any point up to 24 weeks after kidney transplantation
Time frame: up to 6 months
Efficacy failure using a composite endpoint consisting of graft loss, biopsy confirmed acute rejection or graft dysfunction
Time frame: up to 6 months
Positive Oral Glucose Tolerance Test
Time frame: 8 weeks
Repeat Positive Oral Glucose Tolerance Test
Time frame: 6 months
Renal function
Time frame: at 6 months
Acute Rejections
Time frame: up to 6 months
Biopsy confirmed acute rejections
Time frame: up to 6 months
Subject survival
Time frame: up to 6 months
Graft survival
Time frame: up to 6 months
Change from Baseline in HbA1C levels
Time frame: Baseline, week 12 and week 24
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IV \& oral
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Perth, Australia
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Sydney, Australia
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Sydney, Australia
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Brussels, Belgium
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Brussels, Belgium
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Leuven, Belgium
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Liège, Belgium
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Cali, Colombia
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Brno, Czechia
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Hradec Králové, Czechia
...and 90 more locations