EW-ONSET DIABETES MELLITUS AFTER RENAL TRANSPLANTATION. STUDY TO EVALUATE BELATACEPT-BASED VERSUS TACROLIMUS-BASED IMMUNOSUPPRESSIO

Phase 1

• Conditions: MedDRA version: 15.1Level: HLGTClassification code 10018424Term: Glucose metabolism disorders (incl diabetes mellitus)System Organ Class: 10014698 - Endocrine disorders; Adult kidney transplant recipients older than 45 years old with risk of developing prediabetes states after renal transplantation (PREDAT) and diabetes mellitus after renal transplantation (NODAT); MedDRA version: 15.1Level: LLTClassification code 10023438Term: Kidney transplantSystem Organ Class: 100000004865; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2011-006162-40-ES
• Lead Sponsor: Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-03-06
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

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for primary kidney transplantation or re-transplantation in who according to investigator criteria steroids may be withdrawn at 5 days.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

Exclusion Criteria

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.
PRA >30%.
Significant liver disease

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to compare the incidence of glucose metabolism alterations defined as per the American Diabetic Association at any time point up to 6 months after kidney transplantation;Secondary Objective: Acute rejections by signs and symptoms<br>Biopsy confirmed acute rejections<br>Patient survival at 6 months.<br>Graft survival at 6 months.<br>Renal function at 6 months measured as estimated glomerular filtration rate according to MDRD-4 formula. <br>Reported quality of life;Primary end point(s): Incidence of GMA, either PREDAT or NODAT, defined as per ADA criteria;Timepoint(s) of evaluation of this end point: the first 6 months after transplantation

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Acute rejections by signs and symptoms<br>Biopsy confirmed acute rejections<br>Patient survival at 6 months.<br>Graft survival at 6 months.<br>Renal function at 6 months measured as estimated glomerular filtration rate according to MDRD-4 formula. <br>Reported quality of life;Timepoint(s) of evaluation of this end point: the first 6 months after transplantation