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Type: Journal article
Title: Prospective, multicenter, randomized trial to compare incidence of new-onset diabetes mellitus and glucose metabolism in patients receiving cyclosporine microemulsion versus tacrolimus after de novo kidney transplantation
Author: Vincenti, F.
Tuncer, M.
Castagneto, M.
Klinger, M.
Friman, S.
Scheuermann, E.
Wiecek, A.
Russ, G.
Martinek, A.
Nonnast-Daniel, B.
Citation: Transplantation Proceedings, 2005; 37(2):1001-1004
Publisher: Elsevier Science Inc
Issue Date: 2005
ISSN: 0041-1345
Abstract: New-onset diabetes mellitus (NODM) is associated with increased risk of graft failure and death in renal transplant recipients. Some clinical studies have indicated that NODM risk is higher with tacrolimus than cyclosporine, but no comparative trial has used American Diabetic Association (ADA)/World Health Organization (WHO) criteria for diagnosis of diabetes mellitus. The Diabetes Incidence After Renal Transplantation, Neoral C2 Monitoring Versus Tacrolimus (DIRECT) study is a 6-month open-label, multicenter trial comparing the impact of tacrolimus and Neoral (cyclosporine microemulsion) on glucose metabolism in 700 de novo kidney transplant recipients, based on ADA/WHO criteria. Patients are randomized to tacrolimus (C0 monitoring) or Neoral (C2 monitoring), stratified by baseline diabetic status and ethnicity. All patients receive basiliximab, corticosteroids, and mycophenolate mofetil or enteric-coated mycophenolate acid (myfortic). Pooled interim 3-month results from a subset of 115 patients receiving either tacrolimus or Neoral showed that the primary efficacy end-point (biopsy-proven acute rejection [BPAR], graft loss or death) occurred in 11 patients (10%). There were four graft losses and only one death, which occurred after graft loss. Eight patients experienced BPAR (7.3%). Among 99 patients who were nondiabetic at baseline, 14 developed NODM by month 3, 17 developed impaired fasting glucose or impaired glucose tolerance, and another 5 patients received hypoglycemic treatment for at least 14 consecutive days or at the month 3 visit, resulting in a 36% incidence of impaired glucose metabolism. At 3 months, median GFR (Nankivell) was 63.7 mL/min; median serum creatinine was 137 micromol/L. Full complete results are expected in December 2005.
Keywords: DIRECT Study Group
Diabetes Mellitus
Body Weight
Mycophenolic Acid
Adrenal Cortex Hormones
Immunosuppressive Agents
Drug Monitoring
Treatment Failure
Drug Therapy, Combination
Kidney Transplantation
Middle Aged
European Continental Ancestry Group
Tissue Donors
United States
DOI: 10.1016/j.transproceed.2004.12.017
Appears in Collections:Aurora harvest 6
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