Randomized, Open-Label, Phase IV, Korean Study of Kidney Transplant Patients Converting From Cyclosporine to Prolonged-Release Tacrolimus Plus Standard- or Reduced-Dose Corticosteroids
DC Field | Value | Language |
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dc.contributor.author | Baek, C. H. | - |
dc.contributor.author | Kim, C. -D. | - |
dc.contributor.author | Lee, D. R. | - |
dc.contributor.author | Kim, Y. H. | - |
dc.contributor.author | Yang, J. | - |
dc.contributor.author | Kim, B. S. | - |
dc.contributor.author | Lee, J. S. | - |
dc.contributor.author | Han, S. Y. | - |
dc.contributor.author | Kim, S. W. | - |
dc.contributor.author | Lee, S. | - |
dc.contributor.author | Lee, K. W. | - |
dc.contributor.author | Kong, J. M. | - |
dc.contributor.author | Shin, B. C. | - |
dc.contributor.author | Lee, S. H. | - |
dc.contributor.author | Chae, D. W. | - |
dc.contributor.author | Kwon, Y. J. | - |
dc.contributor.author | Jiang, H. | - |
dc.contributor.author | Lee, H. | - |
dc.contributor.author | Park, S. -K. | - |
dc.date.accessioned | 2021-09-01T17:06:18Z | - |
dc.date.available | 2021-09-01T17:06:18Z | - |
dc.date.created | 2021-06-19 | - |
dc.date.issued | 2019-04 | - |
dc.identifier.issn | 0041-1345 | - |
dc.identifier.uri | https://scholar.korea.ac.kr/handle/2021.sw.korea/66545 | - |
dc.description.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. | - |
dc.language | English | - |
dc.language.iso | en | - |
dc.publisher | ELSEVIER SCIENCE INC | - |
dc.subject | INHIBITOR BASED TREATMENT | - |
dc.subject | TERM-FOLLOW-UP | - |
dc.subject | LONG-TERM | - |
dc.subject | CALCINEURIN INHIBITOR | - |
dc.subject | RENAL-TRANSPLANTATION | - |
dc.subject | MYCOPHENOLATE-MOFETIL | - |
dc.subject | INCREASED ADHERENCE | - |
dc.subject | STEROID WITHDRAWAL | - |
dc.subject | GRAFT FAILURE | - |
dc.subject | RECIPIENTS | - |
dc.title | Randomized, Open-Label, Phase IV, Korean Study of Kidney Transplant Patients Converting From Cyclosporine to Prolonged-Release Tacrolimus Plus Standard- or Reduced-Dose Corticosteroids | - |
dc.type | Article | - |
dc.contributor.affiliatedAuthor | Kwon, Y. J. | - |
dc.identifier.doi | 10.1016/j.transproceed.2019.01.057 | - |
dc.identifier.scopusid | 2-s2.0-85064071575 | - |
dc.identifier.wosid | 000466054000019 | - |
dc.identifier.bibliographicCitation | TRANSPLANTATION PROCEEDINGS, v.51, no.3, pp.749 - 760 | - |
dc.relation.isPartOf | TRANSPLANTATION PROCEEDINGS | - |
dc.citation.title | TRANSPLANTATION PROCEEDINGS | - |
dc.citation.volume | 51 | - |
dc.citation.number | 3 | - |
dc.citation.startPage | 749 | - |
dc.citation.endPage | 760 | - |
dc.type.rims | ART | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
dc.relation.journalResearchArea | Immunology | - |
dc.relation.journalResearchArea | Surgery | - |
dc.relation.journalResearchArea | Transplantation | - |
dc.relation.journalWebOfScienceCategory | Immunology | - |
dc.relation.journalWebOfScienceCategory | Surgery | - |
dc.relation.journalWebOfScienceCategory | Transplantation | - |
dc.subject.keywordPlus | INHIBITOR BASED TREATMENT | - |
dc.subject.keywordPlus | TERM-FOLLOW-UP | - |
dc.subject.keywordPlus | LONG-TERM | - |
dc.subject.keywordPlus | CALCINEURIN INHIBITOR | - |
dc.subject.keywordPlus | RENAL-TRANSPLANTATION | - |
dc.subject.keywordPlus | MYCOPHENOLATE-MOFETIL | - |
dc.subject.keywordPlus | INCREASED ADHERENCE | - |
dc.subject.keywordPlus | STEROID WITHDRAWAL | - |
dc.subject.keywordPlus | GRAFT FAILURE | - |
dc.subject.keywordPlus | RECIPIENTS | - |
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