Optimum Immunosuppression in Renal Transplant Recipients.New Onset Diabetes After Transplantation (01-DMPT)

Armando Torres Ramírez

Status and phase: Terminated; Phase 4

Conditions: Diabetes Mellitus, Adult-Onset

Treatments: Drug: CsA with steroid minimization; Drug: Tacrolimus with rapid steroid withdrawal; Drug: Tacrolimus with steroids minimization

Study type: Interventional

Funder types: Other

Identifiers

NCT01002339

FundacionRC

Details and patient eligibility

About

New onset diabetes after renal transplantation (NODAT) is a common and severe complication negatively influencing graft and patient survival. Cyclosporine (CsA) and Tacrolimus are the basis of modern immunosuppression. Tacrolimus is superior to CsA in terms of acute rejection and graft function. However, Tacrolimus increases 2 times the risk of NODAT as compared to CsA.

Full description

New onset diabetes after renal transplantation (NODAT) is a common and severe complication negatively influencing graft and patient survival. CsA and Tacrolimus are the basis of modern immunosuppression. Tacrolimus is superior to CsA in terms of acute rejection and graft function. However, increases 2 times the risk of NODAT as compared to CsA. Objectives: a) To compare the incidence of NODAT and glucose intolerance with 3 different regimes: Tacrolimus with rapid steroid withdrawal; Tacrolimus with steroids minimization; and CsA with steroid minimization; b) To compare acute rejection rate, renal function and graft and patient survival between different regimes; and c) to investigate the influence of different regimes on subclinical atheromatosis. A total of 210 patients will be randomized. The primary efficacy variable will be NODAT or glucose intolerance at 1 year; secondary efficacy variables will be acute rejection, renal function, and changes of carotid intima-media thickness over time.

Enrollment: 134 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Primary renal transplant recipients with end stage renal disease
• No prior history of diabetes mellitus before transplant
• Absence of Immunologic risk defined by the investigator criterion and Panel Reactive Antibody (PRA) < 50%
• Absence of severe infection and hepatitis C or B infection
• Efficient contraception in women during the study

Additionally must meet one of these "Metabolic Criteria

• Recipient age >or =60 or
• Recipient age between 45 and 59 years and at least one of the following metabolic criteria: Prior to transplantation Triglycerides (TGS) >200mg/dl or the combination of a body mass index (BMI)> 27 and Triglycerides>150 mg/dl or the combination of HDL-cholesterol<40 mg/dl for men or <50 mg/dl for women and Triglycerides >150 mg/dl.

Exclusion criteria

• Patients with type I or II diabetes prior to transplantation defined by the American Diabetes Association (ADA) criteria
• Recipient age under 45
• Patients receiving a second renal transplant
• Patients with high immunological risk or PRA (panel reactive antibody level) >or =50%
• Severe infection or hepatitis C or B infection.
• Dual renal transplant or double transplant with any other organ.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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134 participants in 3 patient groups

Tacrolimus with rapid steroid withdrawal

Experimental group

Description:

Basiliximab induction. Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.

Treatment:

Drug: Tacrolimus with rapid steroid withdrawal

Tacrolimus with steroids minimization

Active Comparator group

Description:

Basiliximab induction.Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal

Treatment:

Drug: Tacrolimus with steroids minimization

CsA with steroid minimization

Experimental group

Description:

Basiliximab induction. Ciclosporin A (CsA) plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal

Treatment:

Drug: CsA with steroid minimization