Conversion of stable kidney transplant recipients from a twice daily prograf-based regimen to a once daily modified release tacrolimus-based regimen

R. Alloway, S. Steinberg, K. Khalil, S. Gourishankar, J. Miller, Douglas Norman, S. Hariharan, J. Pirsch, A. Matas, J. Zaltzman, K. Wisemandle, W. Fitzsimmons, M. R. First

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Abstract

Modified release (MR) tacrolimus is an extended release formulation administered once daily (qD). The purpose of this pharmacokinetic (PK) study was to evaluate tacrolimus exposure in stable kidney transplant recipients converted from Prograf twice a day to MR tacrolimus qD. Methods. This was an open-label, multicenter study with a crossover design. Eligible patients were 18 to 65 years of age, more than 6 months posttransplant with stable renal function, and received stable Prograf doses more than 2 weeks prior to enrollment. Patients received Prograf twice a day through day 7; 24-hour PK profiles were obtained on days 1 and 7. Patients were converted to the same milligram-for-milligram daily dose of MR tacrolimus qD in the morning on day 8; 24-hour PK profiles were obtained for MR tacrolimus on days 8, 14, and 21. Laboratory and safety parameters were also evaluated. Results. Most patients (67 of 70) completed all 5 PK profiles. The 90% confidence intervals (CI) for the MR tacrolimus vs Prograf comparison at steady state (days 14 and 21 vs days 1 and 7) were 90.7 and 99.4 for AUC0-24 and 82.7 and 91.9 for C min. MR tacrolimus was well tolerated with a safety profile comparable to that of Prograf. AUC0-24 was highly correlated to Cmin for Prograf (day 1, r = 0.80; day 7, r = 0.84) and MR tacrolimus (day 14, r = 0.92; day 21, r = 0.86). Renal function remained stable after conversion to MR tacrolimus. Conclusion. The steady state PK of MR tacrolimus are equivalent to Prograf after a milligram-for-milligram conversion in stable kidney transplant recipients. The results provide evidence to support a safe 1:1 conversion from Prograf twice a day to MR tacrolimus.

Original languageEnglish (US)
Pages (from-to)867-870
Number of pages4
JournalTransplantation Proceedings
Volume37
Issue number2
DOIs
StatePublished - Mar 2005

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Tacrolimus
Kidney
Pharmacokinetics
Transplant Recipients
Safety

ASJC Scopus subject areas

  • Surgery
  • Transplantation

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Conversion of stable kidney transplant recipients from a twice daily prograf-based regimen to a once daily modified release tacrolimus-based regimen. / Alloway, R.; Steinberg, S.; Khalil, K.; Gourishankar, S.; Miller, J.; Norman, Douglas; Hariharan, S.; Pirsch, J.; Matas, A.; Zaltzman, J.; Wisemandle, K.; Fitzsimmons, W.; First, M. R.

In: Transplantation Proceedings, Vol. 37, No. 2, 03.2005, p. 867-870.

Research output: Contribution to journalArticle

Alloway, R, Steinberg, S, Khalil, K, Gourishankar, S, Miller, J, Norman, D, Hariharan, S, Pirsch, J, Matas, A, Zaltzman, J, Wisemandle, K, Fitzsimmons, W & First, MR 2005, 'Conversion of stable kidney transplant recipients from a twice daily prograf-based regimen to a once daily modified release tacrolimus-based regimen', Transplantation Proceedings, vol. 37, no. 2, pp. 867-870. https://doi.org/10.1016/j.transproceed.2004.12.222
Alloway, R. ; Steinberg, S. ; Khalil, K. ; Gourishankar, S. ; Miller, J. ; Norman, Douglas ; Hariharan, S. ; Pirsch, J. ; Matas, A. ; Zaltzman, J. ; Wisemandle, K. ; Fitzsimmons, W. ; First, M. R. / Conversion of stable kidney transplant recipients from a twice daily prograf-based regimen to a once daily modified release tacrolimus-based regimen. In: Transplantation Proceedings. 2005 ; Vol. 37, No. 2. pp. 867-870.
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abstract = "Modified release (MR) tacrolimus is an extended release formulation administered once daily (qD). The purpose of this pharmacokinetic (PK) study was to evaluate tacrolimus exposure in stable kidney transplant recipients converted from Prograf twice a day to MR tacrolimus qD. Methods. This was an open-label, multicenter study with a crossover design. Eligible patients were 18 to 65 years of age, more than 6 months posttransplant with stable renal function, and received stable Prograf doses more than 2 weeks prior to enrollment. Patients received Prograf twice a day through day 7; 24-hour PK profiles were obtained on days 1 and 7. Patients were converted to the same milligram-for-milligram daily dose of MR tacrolimus qD in the morning on day 8; 24-hour PK profiles were obtained for MR tacrolimus on days 8, 14, and 21. Laboratory and safety parameters were also evaluated. Results. Most patients (67 of 70) completed all 5 PK profiles. The 90{\%} confidence intervals (CI) for the MR tacrolimus vs Prograf comparison at steady state (days 14 and 21 vs days 1 and 7) were 90.7 and 99.4 for AUC0-24 and 82.7 and 91.9 for C min. MR tacrolimus was well tolerated with a safety profile comparable to that of Prograf. AUC0-24 was highly correlated to Cmin for Prograf (day 1, r = 0.80; day 7, r = 0.84) and MR tacrolimus (day 14, r = 0.92; day 21, r = 0.86). Renal function remained stable after conversion to MR tacrolimus. Conclusion. The steady state PK of MR tacrolimus are equivalent to Prograf after a milligram-for-milligram conversion in stable kidney transplant recipients. The results provide evidence to support a safe 1:1 conversion from Prograf twice a day to MR tacrolimus.",
author = "R. Alloway and S. Steinberg and K. Khalil and S. Gourishankar and J. Miller and Douglas Norman and S. Hariharan and J. Pirsch and A. Matas and J. Zaltzman and K. Wisemandle and W. Fitzsimmons and First, {M. R.}",
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T1 - Conversion of stable kidney transplant recipients from a twice daily prograf-based regimen to a once daily modified release tacrolimus-based regimen

AU - Alloway, R.

AU - Steinberg, S.

AU - Khalil, K.

AU - Gourishankar, S.

AU - Miller, J.

AU - Norman, Douglas

AU - Hariharan, S.

AU - Pirsch, J.

AU - Matas, A.

AU - Zaltzman, J.

AU - Wisemandle, K.

AU - Fitzsimmons, W.

AU - First, M. R.

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N2 - Modified release (MR) tacrolimus is an extended release formulation administered once daily (qD). The purpose of this pharmacokinetic (PK) study was to evaluate tacrolimus exposure in stable kidney transplant recipients converted from Prograf twice a day to MR tacrolimus qD. Methods. This was an open-label, multicenter study with a crossover design. Eligible patients were 18 to 65 years of age, more than 6 months posttransplant with stable renal function, and received stable Prograf doses more than 2 weeks prior to enrollment. Patients received Prograf twice a day through day 7; 24-hour PK profiles were obtained on days 1 and 7. Patients were converted to the same milligram-for-milligram daily dose of MR tacrolimus qD in the morning on day 8; 24-hour PK profiles were obtained for MR tacrolimus on days 8, 14, and 21. Laboratory and safety parameters were also evaluated. Results. Most patients (67 of 70) completed all 5 PK profiles. The 90% confidence intervals (CI) for the MR tacrolimus vs Prograf comparison at steady state (days 14 and 21 vs days 1 and 7) were 90.7 and 99.4 for AUC0-24 and 82.7 and 91.9 for C min. MR tacrolimus was well tolerated with a safety profile comparable to that of Prograf. AUC0-24 was highly correlated to Cmin for Prograf (day 1, r = 0.80; day 7, r = 0.84) and MR tacrolimus (day 14, r = 0.92; day 21, r = 0.86). Renal function remained stable after conversion to MR tacrolimus. Conclusion. The steady state PK of MR tacrolimus are equivalent to Prograf after a milligram-for-milligram conversion in stable kidney transplant recipients. The results provide evidence to support a safe 1:1 conversion from Prograf twice a day to MR tacrolimus.

AB - Modified release (MR) tacrolimus is an extended release formulation administered once daily (qD). The purpose of this pharmacokinetic (PK) study was to evaluate tacrolimus exposure in stable kidney transplant recipients converted from Prograf twice a day to MR tacrolimus qD. Methods. This was an open-label, multicenter study with a crossover design. Eligible patients were 18 to 65 years of age, more than 6 months posttransplant with stable renal function, and received stable Prograf doses more than 2 weeks prior to enrollment. Patients received Prograf twice a day through day 7; 24-hour PK profiles were obtained on days 1 and 7. Patients were converted to the same milligram-for-milligram daily dose of MR tacrolimus qD in the morning on day 8; 24-hour PK profiles were obtained for MR tacrolimus on days 8, 14, and 21. Laboratory and safety parameters were also evaluated. Results. Most patients (67 of 70) completed all 5 PK profiles. The 90% confidence intervals (CI) for the MR tacrolimus vs Prograf comparison at steady state (days 14 and 21 vs days 1 and 7) were 90.7 and 99.4 for AUC0-24 and 82.7 and 91.9 for C min. MR tacrolimus was well tolerated with a safety profile comparable to that of Prograf. AUC0-24 was highly correlated to Cmin for Prograf (day 1, r = 0.80; day 7, r = 0.84) and MR tacrolimus (day 14, r = 0.92; day 21, r = 0.86). Renal function remained stable after conversion to MR tacrolimus. Conclusion. The steady state PK of MR tacrolimus are equivalent to Prograf after a milligram-for-milligram conversion in stable kidney transplant recipients. The results provide evidence to support a safe 1:1 conversion from Prograf twice a day to MR tacrolimus.

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