A 6-Month, Multicenter, Single-Arm Pilot Study to Evaluate the Efficacy and Safety of Generic Tacrolimus (TacroBell) After Primary Renal Transplantation

S. J. Kim, K. H. Huh, D. J. Han, I. S. Moon, S. J. Kim, Y. L. Kim, H. C. Kim, S. Lee, C. M. Kang, B. H. Cho, Y. S. Kim

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Abstract

Objective: Tacrolimus has been shown to be an important immunosuppressive agent in organ and bone marrow transplantation. Previously, we reported that there were no statistically significant differences between the pharmacokinetic parameters of the oral formulation of generic tacrolimus (TacroBell) and the conventional formulation (Prograf). This study was designed to evaluate the efficacy and safety of oral capsules of TacroBell in de novo renal transplantation. Methods: Ninety-six renal transplant recipients from 9 transplantation centers in South Korea were enrolled between November 2005 and July 2007. De novo renal recipients ranged from 19-65 years old. Ninety-four patients who underwent renal transplantation were administered study drug at least one time in the intent-to-treat (ITT) analysis. This phase 4 clinical trial was a 26-week, open-label, noncomparative, multicenter study. Results: An acute rejection episode developed in 10/94 recipients (10.6%, 95% confidence interval, 4.4%-16.9%). There were no patient deaths during the study. The 6-month graft survival rate was 96.8%. Conclusion: Based on this study, treatment with TacroBell is considered to be efficient and safe after primary renal transplantation.

Original languageEnglish
Pages (from-to)1671-1674
Number of pages4
JournalTransplantation Proceedings
Volume41
Issue number5
DOIs
Publication statusPublished - 2009 Jun 1

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Tacrolimus
Kidney Transplantation
Safety
Phase IV Clinical Trials
Kidney
Republic of Korea
Graft Survival
Immunosuppressive Agents
Bone Marrow Transplantation
Multicenter Studies
Capsules
Survival Rate
Pharmacokinetics
Transplantation
Confidence Intervals
Pharmaceutical Preparations
Therapeutics

All Science Journal Classification (ASJC) codes

  • Surgery
  • Transplantation

Cite this

Kim, S. J. ; Huh, K. H. ; Han, D. J. ; Moon, I. S. ; Kim, S. J. ; Kim, Y. L. ; Kim, H. C. ; Lee, S. ; Kang, C. M. ; Cho, B. H. ; Kim, Y. S. / A 6-Month, Multicenter, Single-Arm Pilot Study to Evaluate the Efficacy and Safety of Generic Tacrolimus (TacroBell) After Primary Renal Transplantation. In: Transplantation Proceedings. 2009 ; Vol. 41, No. 5. pp. 1671-1674.
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abstract = "Objective: Tacrolimus has been shown to be an important immunosuppressive agent in organ and bone marrow transplantation. Previously, we reported that there were no statistically significant differences between the pharmacokinetic parameters of the oral formulation of generic tacrolimus (TacroBell) and the conventional formulation (Prograf). This study was designed to evaluate the efficacy and safety of oral capsules of TacroBell in de novo renal transplantation. Methods: Ninety-six renal transplant recipients from 9 transplantation centers in South Korea were enrolled between November 2005 and July 2007. De novo renal recipients ranged from 19-65 years old. Ninety-four patients who underwent renal transplantation were administered study drug at least one time in the intent-to-treat (ITT) analysis. This phase 4 clinical trial was a 26-week, open-label, noncomparative, multicenter study. Results: An acute rejection episode developed in 10/94 recipients (10.6{\%}, 95{\%} confidence interval, 4.4{\%}-16.9{\%}). There were no patient deaths during the study. The 6-month graft survival rate was 96.8{\%}. Conclusion: Based on this study, treatment with TacroBell is considered to be efficient and safe after primary renal transplantation.",
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A 6-Month, Multicenter, Single-Arm Pilot Study to Evaluate the Efficacy and Safety of Generic Tacrolimus (TacroBell) After Primary Renal Transplantation. / Kim, S. J.; Huh, K. H.; Han, D. J.; Moon, I. S.; Kim, S. J.; Kim, Y. L.; Kim, H. C.; Lee, S.; Kang, C. M.; Cho, B. H.; Kim, Y. S.

In: Transplantation Proceedings, Vol. 41, No. 5, 01.06.2009, p. 1671-1674.

Research output: Contribution to journalArticle

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T1 - A 6-Month, Multicenter, Single-Arm Pilot Study to Evaluate the Efficacy and Safety of Generic Tacrolimus (TacroBell) After Primary Renal Transplantation

AU - Kim, S. J.

AU - Huh, K. H.

AU - Han, D. J.

AU - Moon, I. S.

AU - Kim, S. J.

AU - Kim, Y. L.

AU - Kim, H. C.

AU - Lee, S.

AU - Kang, C. M.

AU - Cho, B. H.

AU - Kim, Y. S.

PY - 2009/6/1

Y1 - 2009/6/1

N2 - Objective: Tacrolimus has been shown to be an important immunosuppressive agent in organ and bone marrow transplantation. Previously, we reported that there were no statistically significant differences between the pharmacokinetic parameters of the oral formulation of generic tacrolimus (TacroBell) and the conventional formulation (Prograf). This study was designed to evaluate the efficacy and safety of oral capsules of TacroBell in de novo renal transplantation. Methods: Ninety-six renal transplant recipients from 9 transplantation centers in South Korea were enrolled between November 2005 and July 2007. De novo renal recipients ranged from 19-65 years old. Ninety-four patients who underwent renal transplantation were administered study drug at least one time in the intent-to-treat (ITT) analysis. This phase 4 clinical trial was a 26-week, open-label, noncomparative, multicenter study. Results: An acute rejection episode developed in 10/94 recipients (10.6%, 95% confidence interval, 4.4%-16.9%). There were no patient deaths during the study. The 6-month graft survival rate was 96.8%. Conclusion: Based on this study, treatment with TacroBell is considered to be efficient and safe after primary renal transplantation.

AB - Objective: Tacrolimus has been shown to be an important immunosuppressive agent in organ and bone marrow transplantation. Previously, we reported that there were no statistically significant differences between the pharmacokinetic parameters of the oral formulation of generic tacrolimus (TacroBell) and the conventional formulation (Prograf). This study was designed to evaluate the efficacy and safety of oral capsules of TacroBell in de novo renal transplantation. Methods: Ninety-six renal transplant recipients from 9 transplantation centers in South Korea were enrolled between November 2005 and July 2007. De novo renal recipients ranged from 19-65 years old. Ninety-four patients who underwent renal transplantation were administered study drug at least one time in the intent-to-treat (ITT) analysis. This phase 4 clinical trial was a 26-week, open-label, noncomparative, multicenter study. Results: An acute rejection episode developed in 10/94 recipients (10.6%, 95% confidence interval, 4.4%-16.9%). There were no patient deaths during the study. The 6-month graft survival rate was 96.8%. Conclusion: Based on this study, treatment with TacroBell is considered to be efficient and safe after primary renal transplantation.

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