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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.
Transplant Proc 2005; 37(2):1001-4TP

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.

Authors+Show Affiliations

Kidney Transplant Service, UCSF, San Francisco, California 94143, USA. VincentiF@surgery.ucsf.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

15848604

Citation

Vincenti, F, et al. "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." Transplantation Proceedings, vol. 37, no. 2, 2005, pp. 1001-4.
Vincenti F, Tuncer M, Castagneto M, et al. 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. Transplant Proc. 2005;37(2):1001-4.
Vincenti, F., Tuncer, M., Castagneto, M., Klinger, M., Friman, S., Scheuermann, E. H., ... Nonnast-Daniel, B. (2005). 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. Transplantation Proceedings, 37(2), pp. 1001-4.
Vincenti F, et al. 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. Transplant Proc. 2005;37(2):1001-4. PubMed PMID: 15848604.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Vincenti,F, AU - Tuncer,M, AU - Castagneto,M, AU - Klinger,M, AU - Friman,S, AU - Scheuermann,E-H, AU - Wiecek,A, AU - Russ,G R, AU - Martinek,A, AU - Nonnast-Daniel,B, AU - ,, PY - 2005/4/26/pubmed PY - 2005/9/27/medline PY - 2005/4/26/entrez SP - 1001 EP - 4 JF - Transplantation proceedings JO - Transplant. Proc. VL - 37 IS - 2 N2 - 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. SN - 0041-1345 UR - https://www.unboundmedicine.com/medline/citation/15848604/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_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0041-1345(04)01455-1 DB - PRIME DP - Unbound Medicine ER -