Randomized, Open-Label, Phase IV, Korean Study of Kidney Transplant Patients Converting From Cyclosporine to Prolonged-Release Tacrolimus Plus Standard- or Reduced-Dose Corticosteroids

C. H. Baek, C. D. Kim, D. R. Lee, Y. H. Kim, J. Yang, B. S. Kim, J. S. Lee, S. Y. Han, S. W. Kim, S. Lee, K. W. Lee, J. M. Kong, B. C. Shin, S. H. Lee, D. W. Chae, Young-Joo Kwon, H. Jiang, H. Lee, S. K. Park

Research output: Contribution to journalArticle

Abstract

Background: This 24-week, multicenter, randomized, exploratory, comparative, open-label, phase-IV study assessed the safety and efficacy of prolonged-release tacrolimus (PR-T) with reduced-dose versus standard-dose corticosteroids in stable kidney transplant recipients in Korea after converting from cyclosporine-based therapy. Methods: At baseline, patients were converted from cyclosporine-based to PR-T-based immunosuppression and randomized (1:1) to receive either corticosteroids maintained at prestudy dose (standard-dose group) or tapered from week 4 to 50% of the prestudy dose by week 12 (reduced-dose group). Patients were seen at baseline and weeks 1, 4, 12, and 24. The primary endpoint was change in estimated glomerular filtration rate (Modification-of-Diet-in-Renal-Disease-4) between baseline and week 24. Secondary endpoints included either acute rejection or patient-reported satisfaction with PR-T. Adverse events (AEs) were recorded. Results: Overall, 150 patients were randomized into a reduced-dose group (n = 73) and a standard-dose group (n = 77). At week 24, mean ± standard deviation for corticosteroid dose was 2.5 ± 0.9 mg and 5.0 ± 1.3 mg, respectively. Mean change in estimated glomerular filtration rate from baseline to week 24 was +1.5 ± 9.1 mL/min/1.73 m 2 (P =.1567) and +3.4 ± 10.6 mL/min/1.73 m 2 (P =.0065), respectively, and not significantly different between groups. There were no acute rejection episodes. Most respondents (>70%) considered PR-T more convenient than cyclosporine. AE incidence was similar between groups. The most common AEs experienced by ≥3% of patients in either treatment group were gastrointestinal events (20.8% and 28.6% of patients receiving reduced- and standard-dose corticosteroids, respectively). Most AEs in both treatment groups were mild or moderate in severity. Conclusion: Renal function was maintained following conversion from cyclosporine to PR-T, irrespective of corticosteroid regimen; PR-T enables reduced corticosteroid dosage.

Original languageEnglish
Pages (from-to)749-760
Number of pages12
JournalTransplantation Proceedings
Volume51
Issue number3
DOIs
Publication statusPublished - 2019 Apr 1

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Tacrolimus
Cyclosporine
Adrenal Cortex Hormones
Transplants
Kidney
Glomerular Filtration Rate
Diet Therapy
Korea
Patient Satisfaction
Immunosuppression
Therapeutics
Safety
Incidence

ASJC Scopus subject areas

  • Surgery
  • Transplantation

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Randomized, Open-Label, Phase IV, Korean Study of Kidney Transplant Patients Converting From Cyclosporine to Prolonged-Release Tacrolimus Plus Standard- or Reduced-Dose Corticosteroids. / Baek, C. H.; Kim, C. D.; Lee, D. R.; Kim, Y. H.; Yang, J.; Kim, B. S.; Lee, J. S.; Han, S. Y.; Kim, S. W.; Lee, S.; Lee, K. W.; Kong, J. M.; Shin, B. C.; Lee, S. H.; Chae, D. W.; Kwon, Young-Joo; Jiang, H.; Lee, H.; Park, S. K.

In: Transplantation Proceedings, Vol. 51, No. 3, 01.04.2019, p. 749-760.

Research output: Contribution to journalArticle

Baek, CH, Kim, CD, Lee, DR, Kim, YH, Yang, J, Kim, BS, Lee, JS, Han, SY, Kim, SW, Lee, S, Lee, KW, Kong, JM, Shin, BC, Lee, SH, Chae, DW, Kwon, Y-J, Jiang, H, Lee, H & Park, SK 2019, 'Randomized, Open-Label, Phase IV, Korean Study of Kidney Transplant Patients Converting From Cyclosporine to Prolonged-Release Tacrolimus Plus Standard- or Reduced-Dose Corticosteroids', Transplantation Proceedings, vol. 51, no. 3, pp. 749-760. https://doi.org/10.1016/j.transproceed.2019.01.057
Baek, C. H. ; Kim, C. D. ; Lee, D. R. ; Kim, Y. H. ; Yang, J. ; Kim, B. S. ; Lee, J. S. ; Han, S. Y. ; Kim, S. W. ; Lee, S. ; Lee, K. W. ; Kong, J. M. ; Shin, B. C. ; Lee, S. H. ; Chae, D. W. ; Kwon, Young-Joo ; Jiang, H. ; Lee, H. ; Park, S. K. / Randomized, Open-Label, Phase IV, Korean Study of Kidney Transplant Patients Converting From Cyclosporine to Prolonged-Release Tacrolimus Plus Standard- or Reduced-Dose Corticosteroids. In: Transplantation Proceedings. 2019 ; Vol. 51, No. 3. pp. 749-760.
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abstract = "Background: This 24-week, multicenter, randomized, exploratory, comparative, open-label, phase-IV study assessed the safety and efficacy of prolonged-release tacrolimus (PR-T) with reduced-dose versus standard-dose corticosteroids in stable kidney transplant recipients in Korea after converting from cyclosporine-based therapy. Methods: At baseline, patients were converted from cyclosporine-based to PR-T-based immunosuppression and randomized (1:1) to receive either corticosteroids maintained at prestudy dose (standard-dose group) or tapered from week 4 to 50{\%} of the prestudy dose by week 12 (reduced-dose group). Patients were seen at baseline and weeks 1, 4, 12, and 24. The primary endpoint was change in estimated glomerular filtration rate (Modification-of-Diet-in-Renal-Disease-4) between baseline and week 24. Secondary endpoints included either acute rejection or patient-reported satisfaction with PR-T. Adverse events (AEs) were recorded. Results: Overall, 150 patients were randomized into a reduced-dose group (n = 73) and a standard-dose group (n = 77). At week 24, mean ± standard deviation for corticosteroid dose was 2.5 ± 0.9 mg and 5.0 ± 1.3 mg, respectively. Mean change in estimated glomerular filtration rate from baseline to week 24 was +1.5 ± 9.1 mL/min/1.73 m 2 (P =.1567) and +3.4 ± 10.6 mL/min/1.73 m 2 (P =.0065), respectively, and not significantly different between groups. There were no acute rejection episodes. Most respondents (>70{\%}) considered PR-T more convenient than cyclosporine. AE incidence was similar between groups. The most common AEs experienced by ≥3{\%} of patients in either treatment group were gastrointestinal events (20.8{\%} and 28.6{\%} of patients receiving reduced- and standard-dose corticosteroids, respectively). Most AEs in both treatment groups were mild or moderate in severity. Conclusion: Renal function was maintained following conversion from cyclosporine to PR-T, irrespective of corticosteroid regimen; PR-T enables reduced corticosteroid dosage.",
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T1 - Randomized, Open-Label, Phase IV, Korean Study of Kidney Transplant Patients Converting From Cyclosporine to Prolonged-Release Tacrolimus Plus Standard- or Reduced-Dose Corticosteroids

AU - Baek, C. H.

AU - Kim, C. D.

AU - Lee, D. R.

AU - Kim, Y. H.

AU - Yang, J.

AU - Kim, B. S.

AU - Lee, J. S.

AU - Han, S. Y.

AU - Kim, S. W.

AU - Lee, S.

AU - Lee, K. W.

AU - Kong, J. M.

AU - Shin, B. C.

AU - Lee, S. H.

AU - Chae, D. W.

AU - Kwon, Young-Joo

AU - Jiang, H.

AU - Lee, H.

AU - Park, S. K.

PY - 2019/4/1

Y1 - 2019/4/1

N2 - Background: This 24-week, multicenter, randomized, exploratory, comparative, open-label, phase-IV study assessed the safety and efficacy of prolonged-release tacrolimus (PR-T) with reduced-dose versus standard-dose corticosteroids in stable kidney transplant recipients in Korea after converting from cyclosporine-based therapy. Methods: At baseline, patients were converted from cyclosporine-based to PR-T-based immunosuppression and randomized (1:1) to receive either corticosteroids maintained at prestudy dose (standard-dose group) or tapered from week 4 to 50% of the prestudy dose by week 12 (reduced-dose group). Patients were seen at baseline and weeks 1, 4, 12, and 24. The primary endpoint was change in estimated glomerular filtration rate (Modification-of-Diet-in-Renal-Disease-4) between baseline and week 24. Secondary endpoints included either acute rejection or patient-reported satisfaction with PR-T. Adverse events (AEs) were recorded. Results: Overall, 150 patients were randomized into a reduced-dose group (n = 73) and a standard-dose group (n = 77). At week 24, mean ± standard deviation for corticosteroid dose was 2.5 ± 0.9 mg and 5.0 ± 1.3 mg, respectively. Mean change in estimated glomerular filtration rate from baseline to week 24 was +1.5 ± 9.1 mL/min/1.73 m 2 (P =.1567) and +3.4 ± 10.6 mL/min/1.73 m 2 (P =.0065), respectively, and not significantly different between groups. There were no acute rejection episodes. Most respondents (>70%) considered PR-T more convenient than cyclosporine. AE incidence was similar between groups. The most common AEs experienced by ≥3% of patients in either treatment group were gastrointestinal events (20.8% and 28.6% of patients receiving reduced- and standard-dose corticosteroids, respectively). Most AEs in both treatment groups were mild or moderate in severity. Conclusion: Renal function was maintained following conversion from cyclosporine to PR-T, irrespective of corticosteroid regimen; PR-T enables reduced corticosteroid dosage.

AB - Background: This 24-week, multicenter, randomized, exploratory, comparative, open-label, phase-IV study assessed the safety and efficacy of prolonged-release tacrolimus (PR-T) with reduced-dose versus standard-dose corticosteroids in stable kidney transplant recipients in Korea after converting from cyclosporine-based therapy. Methods: At baseline, patients were converted from cyclosporine-based to PR-T-based immunosuppression and randomized (1:1) to receive either corticosteroids maintained at prestudy dose (standard-dose group) or tapered from week 4 to 50% of the prestudy dose by week 12 (reduced-dose group). Patients were seen at baseline and weeks 1, 4, 12, and 24. The primary endpoint was change in estimated glomerular filtration rate (Modification-of-Diet-in-Renal-Disease-4) between baseline and week 24. Secondary endpoints included either acute rejection or patient-reported satisfaction with PR-T. Adverse events (AEs) were recorded. Results: Overall, 150 patients were randomized into a reduced-dose group (n = 73) and a standard-dose group (n = 77). At week 24, mean ± standard deviation for corticosteroid dose was 2.5 ± 0.9 mg and 5.0 ± 1.3 mg, respectively. Mean change in estimated glomerular filtration rate from baseline to week 24 was +1.5 ± 9.1 mL/min/1.73 m 2 (P =.1567) and +3.4 ± 10.6 mL/min/1.73 m 2 (P =.0065), respectively, and not significantly different between groups. There were no acute rejection episodes. Most respondents (>70%) considered PR-T more convenient than cyclosporine. AE incidence was similar between groups. The most common AEs experienced by ≥3% of patients in either treatment group were gastrointestinal events (20.8% and 28.6% of patients receiving reduced- and standard-dose corticosteroids, respectively). Most AEs in both treatment groups were mild or moderate in severity. Conclusion: Renal function was maintained following conversion from cyclosporine to PR-T, irrespective of corticosteroid regimen; PR-T enables reduced corticosteroid dosage.

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