A multicenter, prospective study of C2-monitored cyclosporine microemulsion in a U.S. population of de novo renal transplant recipients

Flavio Vincenti, Robert Mendez, John Curtis, Jimmy Light, Thomas Pearson, You Min Wu, Stephen M. Katz, Enver Akalin, Robert Esterl, Kristene Gugliuzza, Fuad Shihab, Stanley Jordan, Johann Jonsson, Ernesto Molmenti, Ralph Barbeito

Research output: Contribution to journalArticle

15 Citations (Scopus)

Abstract

Background. Monitoring cyclosporine microemulsion (CsA-ME; Neoral) exposure 2 hours postdose (C2) has been reported to optimize the efficacy and safety of CsA-ME therapy. The addition of induction therapy to a maintenance regimen including CsA-ME C2 monitoring has not been evaluated. Methods. In all, 123 adult renal transplant recipients were recruited at 14 U.S. centers for this 6-month study. CsA-ME dose was to be titrated to attain C2 targets of 1700 and 1500 ng/ml during posttransplant months 1 and 2, respectively. After 2 months, patients were randomized to one of two groups with different, decreasing C2 targets. Basiliximab, mycophenolate mofetil, and corticosteroids completed the study immunosuppression. Results. Of the 119 evaluable patients, 76% were male, 22% African American, and 66% deceased donor recipients. Biopsy-proven acute rejection occurred in 10 patients (9.3%); there were two failed grafts and one death. Serum creatinine and calculated GFR values suggest good renal function, with month 6 medians of 1.5 ng/ml and 67 ml/min/ 1.73m2. Safety and tolerability assessments revealed no unexpected outcomes. Observed C2 levels were generally lower than protocol targets, particularly in the first weeks posttransplantation. Conclusions. The striking efficacy and outcomes may have been achieved in this study with lower C2 levels of CsA-ME because of the addition of basiliximab induction.

Original languageEnglish (US)
Pages (from-to)910-916
Number of pages7
JournalTransplantation
Volume80
Issue number7
DOIs
StatePublished - Oct 15 2005
Externally publishedYes

Fingerprint

Cyclosporine
Multicenter Studies
Prospective Studies
Kidney
Population
Mycophenolic Acid
Safety
African Americans
Immunosuppression
Creatinine
Adrenal Cortex Hormones
Maintenance
Tissue Donors
Transplants
Biopsy
Therapeutics
Serum
Transplant Recipients
basiliximab

Keywords

  • C2
  • Cyclosporine
  • Kidney transplantation
  • Rejection

ASJC Scopus subject areas

  • Transplantation
  • Immunology

Cite this

A multicenter, prospective study of C2-monitored cyclosporine microemulsion in a U.S. population of de novo renal transplant recipients. / Vincenti, Flavio; Mendez, Robert; Curtis, John; Light, Jimmy; Pearson, Thomas; Wu, You Min; Katz, Stephen M.; Akalin, Enver; Esterl, Robert; Gugliuzza, Kristene; Shihab, Fuad; Jordan, Stanley; Jonsson, Johann; Molmenti, Ernesto; Barbeito, Ralph.

In: Transplantation, Vol. 80, No. 7, 15.10.2005, p. 910-916.

Research output: Contribution to journalArticle

Vincenti, F, Mendez, R, Curtis, J, Light, J, Pearson, T, Wu, YM, Katz, SM, Akalin, E, Esterl, R, Gugliuzza, K, Shihab, F, Jordan, S, Jonsson, J, Molmenti, E & Barbeito, R 2005, 'A multicenter, prospective study of C2-monitored cyclosporine microemulsion in a U.S. population of de novo renal transplant recipients', Transplantation, vol. 80, no. 7, pp. 910-916. https://doi.org/10.1097/01.TP.0000173802.70980.50
Vincenti, Flavio ; Mendez, Robert ; Curtis, John ; Light, Jimmy ; Pearson, Thomas ; Wu, You Min ; Katz, Stephen M. ; Akalin, Enver ; Esterl, Robert ; Gugliuzza, Kristene ; Shihab, Fuad ; Jordan, Stanley ; Jonsson, Johann ; Molmenti, Ernesto ; Barbeito, Ralph. / A multicenter, prospective study of C2-monitored cyclosporine microemulsion in a U.S. population of de novo renal transplant recipients. In: Transplantation. 2005 ; Vol. 80, No. 7. pp. 910-916.
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abstract = "Background. Monitoring cyclosporine microemulsion (CsA-ME; Neoral) exposure 2 hours postdose (C2) has been reported to optimize the efficacy and safety of CsA-ME therapy. The addition of induction therapy to a maintenance regimen including CsA-ME C2 monitoring has not been evaluated. Methods. In all, 123 adult renal transplant recipients were recruited at 14 U.S. centers for this 6-month study. CsA-ME dose was to be titrated to attain C2 targets of 1700 and 1500 ng/ml during posttransplant months 1 and 2, respectively. After 2 months, patients were randomized to one of two groups with different, decreasing C2 targets. Basiliximab, mycophenolate mofetil, and corticosteroids completed the study immunosuppression. Results. Of the 119 evaluable patients, 76{\%} were male, 22{\%} African American, and 66{\%} deceased donor recipients. Biopsy-proven acute rejection occurred in 10 patients (9.3{\%}); there were two failed grafts and one death. Serum creatinine and calculated GFR values suggest good renal function, with month 6 medians of 1.5 ng/ml and 67 ml/min/ 1.73m2. Safety and tolerability assessments revealed no unexpected outcomes. Observed C2 levels were generally lower than protocol targets, particularly in the first weeks posttransplantation. Conclusions. The striking efficacy and outcomes may have been achieved in this study with lower C2 levels of CsA-ME because of the addition of basiliximab induction.",
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T1 - A multicenter, prospective study of C2-monitored cyclosporine microemulsion in a U.S. population of de novo renal transplant recipients

AU - Vincenti, Flavio

AU - Mendez, Robert

AU - Curtis, John

AU - Light, Jimmy

AU - Pearson, Thomas

AU - Wu, You Min

AU - Katz, Stephen M.

AU - Akalin, Enver

AU - Esterl, Robert

AU - Gugliuzza, Kristene

AU - Shihab, Fuad

AU - Jordan, Stanley

AU - Jonsson, Johann

AU - Molmenti, Ernesto

AU - Barbeito, Ralph

PY - 2005/10/15

Y1 - 2005/10/15

N2 - Background. Monitoring cyclosporine microemulsion (CsA-ME; Neoral) exposure 2 hours postdose (C2) has been reported to optimize the efficacy and safety of CsA-ME therapy. The addition of induction therapy to a maintenance regimen including CsA-ME C2 monitoring has not been evaluated. Methods. In all, 123 adult renal transplant recipients were recruited at 14 U.S. centers for this 6-month study. CsA-ME dose was to be titrated to attain C2 targets of 1700 and 1500 ng/ml during posttransplant months 1 and 2, respectively. After 2 months, patients were randomized to one of two groups with different, decreasing C2 targets. Basiliximab, mycophenolate mofetil, and corticosteroids completed the study immunosuppression. Results. Of the 119 evaluable patients, 76% were male, 22% African American, and 66% deceased donor recipients. Biopsy-proven acute rejection occurred in 10 patients (9.3%); there were two failed grafts and one death. Serum creatinine and calculated GFR values suggest good renal function, with month 6 medians of 1.5 ng/ml and 67 ml/min/ 1.73m2. Safety and tolerability assessments revealed no unexpected outcomes. Observed C2 levels were generally lower than protocol targets, particularly in the first weeks posttransplantation. Conclusions. The striking efficacy and outcomes may have been achieved in this study with lower C2 levels of CsA-ME because of the addition of basiliximab induction.

AB - Background. Monitoring cyclosporine microemulsion (CsA-ME; Neoral) exposure 2 hours postdose (C2) has been reported to optimize the efficacy and safety of CsA-ME therapy. The addition of induction therapy to a maintenance regimen including CsA-ME C2 monitoring has not been evaluated. Methods. In all, 123 adult renal transplant recipients were recruited at 14 U.S. centers for this 6-month study. CsA-ME dose was to be titrated to attain C2 targets of 1700 and 1500 ng/ml during posttransplant months 1 and 2, respectively. After 2 months, patients were randomized to one of two groups with different, decreasing C2 targets. Basiliximab, mycophenolate mofetil, and corticosteroids completed the study immunosuppression. Results. Of the 119 evaluable patients, 76% were male, 22% African American, and 66% deceased donor recipients. Biopsy-proven acute rejection occurred in 10 patients (9.3%); there were two failed grafts and one death. Serum creatinine and calculated GFR values suggest good renal function, with month 6 medians of 1.5 ng/ml and 67 ml/min/ 1.73m2. Safety and tolerability assessments revealed no unexpected outcomes. Observed C2 levels were generally lower than protocol targets, particularly in the first weeks posttransplantation. Conclusions. The striking efficacy and outcomes may have been achieved in this study with lower C2 levels of CsA-ME because of the addition of basiliximab induction.

KW - C2

KW - Cyclosporine

KW - Kidney transplantation

KW - Rejection

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