EW-ONSET DIABETES MELLITUS AFTER RENAL TRANSPLANTATION. A MULTICENTRE, PROSPECTIVE, RANDOMIZED, OPEN STUDY TO EVALUATE BELATACEPT-BASED VERSUS TACROLIMUS-BASED IMMUNOSUPPRESSIO

Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)0 个研究点目标入组 0 人开始时间: 2013年3月6日最近更新: 2022年8月8日

适应症

试验速览

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•Age ? 45 years of age.
•Patients with high-risk of GMA after renal transplantation defined as:
•a) Patients aged ? 60 years.
•b) Patients aged ? 45 accomplishing one of the following combinations:
•b.1) Serum triglycerides > 200 mg/ml.
•b.2) The combination of body mass index (BMI) > 27 kg/m2 and serum triclycerides > 150 mg/ml.
•b.3) The combination of serum triglycerides > 150 mg/ml and serum HDL-cholesterol < 50 mg/ml in women or < 40 mg/ml in men.
•End stage kidney disease and a suitable candidate for primary kidney transplantation or re-transplantation in who according to investigator criteria steroids may be withdrawn at 5 days.
•Receiving a kidney transplant from a deceased or living (non HLA identical) donor with compatible AB0 blood type.
•Absence of Diabetes Mellitus diagnose prior to transplantation Negative serology for hepatitis B and C virus.
•Positive serology (VCA) for EBV infection.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 50
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 40

•Seronegative or unknown EBV serostatus
•Patients with tuberculosis who have not been treated for latent infection.
•Patients at high risk for polyoma virus-associated nephropathy, which is mostly due to BK virus infection.
•Receiving or having previously received an organ transplant other than a kidney.
•Recipient of dual kidney transplantation.
•Recipient of a graft from a non-heart-beating donor.
•Cold ischemia time of the donor kidney > 30 hours.
•Significant liver disease

发起方

Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)