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Optimum Immunosuppression in Renal Transplant Recipients.New Onset Diabetes After Transplantation

NCT01002339 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2024-10-22

Study results available
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Summary

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.

Conditions

  • Diabetes Mellitus, Adult-Onset

Interventions

DRUG

Tacrolimus with rapid steroid withdrawal

* Basiliximab induction (4 mg i.v., days 0 and 4). * Corticosteroids: 0.5 gr of i.v. Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. * Tacrolimus: 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month and then 5-8 ng/ml. * Mycophenolate mofetil 1 gr b.i.d. for the first month and then 500 mg b.i.d.

DRUG

Tacrolimus with steroids minimization

* Basiliximab induction (4 mg i.v., days 0 an 4) * Corticosteroids: 0.5 gr of i.v. MP intraoperatively and 60 mg on the first day, followed by oral doses of prednisone starting with 0.3 mg/Kg/day, and gradual weekly tapering to complete discontinuation over 6 months. * Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month and then 5-8 ng/ml. * Mycophenolate mofetil 1 gr b.i.d. for the first month and then 500 mg b.i.d.

DRUG

CsA with steroid minimization

* Basiliximab induction (4 mg i.v., days 0 an 4) * Corticosteroids: 0.5 gr of i.v. MP intraoperatively and 60 mg on the first day, followed by oral doses of prednisone starting with 0.3 mg/Kg/day, and gradual weekly tapering to complete discontinuation over 6 months. * CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month and then 100-150 ng/ml. * Mycophenolate mofetil 1 gr b.i.d

Sponsors & Collaborators

  • Armando Torres Ramírez

    lead OTHER

Principal Investigators

  • Armando Torres, PhD · Fundación Canaria para la Investigación Biomédica Rafael Clavijo

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2014-02-28
Completion
2015-06-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01002339 on ClinicalTrials.gov