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Clinical Study of Standard- vs Reduced-Dose Tacrolimus Combined With Generic Mycophenolate Mofetil in De Novo Kidney Transplantation: A Prospective Randomized Trial

DC Field Value Language
dc.contributor.authorBang, JB-
dc.contributor.authorOh, CK-
dc.contributor.authorJu, MK-
dc.contributor.authorKim, SJ-
dc.contributor.authorYu, HC-
dc.contributor.authorLee, SH-
dc.date.accessioned2022-10-28T05:28:45Z-
dc.date.available2022-10-28T05:28:45Z-
dc.date.issued2020-
dc.identifier.issn0041-1345-
dc.identifier.urihttp://repository.ajou.ac.kr/handle/201003/22427-
dc.description.abstractBACKGROUND: The lowering of calcineurin inhibitor exposure is possibly considered as the proper strategy to prevent calcineurin inhibitor-induced nephrotoxicity in kidney transplant. This clinical study was designed to compare the efficacy and tolerability of reduced-dose tacrolimus with standard-dose mycophenolate mofetil (MMF) vs standard-dose tacrolimus with reduced-dose MMF.

METHODS: A prospective, multicenter, open-label, randomized, and parallel-group clinical trial was conducted at 4 transplant centers in Korea. A total sample size was 108, and eligible patients were randomly assigned in a 1:1 ratio to either reduced-dose tacrolimus with standard-dose MMF (the study group) or standard-dose tacrolimus with reduced-dose MMF (the control group) for 6 months in de novo kidney transplant recipients. Graft function, the incidence of efficacy failure, and adverse events were compared.

RESULTS: The mean estimated glomerular filtration rate at 6 months post-transplantation was 69.83 +/- 16.68 mL/min/1.73 m(2) in the study group and 69.92 +/- 17.55 mL/min/1.73 m(2) in the control group (P > .05). The overall incidence of biopsy-proven acute rejection was 3.64% (n = 2) in the study group, compared to 3.77% (n = 2) in the control group (P > .05). There was no graft loss, death, or loss of follow-up in either group.

CONCLUSION: In conclusion, the results suggest that tacrolimus minimization with standard-dose MMF provides adequate immunosuppression with proper renal function and similar rate of incidence of acute rejection compared with the regimen including standard-dose tacrolimus with reduced-dose MMF.
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dc.language.isoen-
dc.subject.MESHAdult-
dc.subject.MESHDrug Therapy, Combination-
dc.subject.MESHDrugs, Generic-
dc.subject.MESHFemale-
dc.subject.MESHGlomerular Filtration Rate-
dc.subject.MESHGraft Rejection-
dc.subject.MESHHumans-
dc.subject.MESHImmunosuppression Therapy-
dc.subject.MESHImmunosuppressive Agents-
dc.subject.MESHIncidence-
dc.subject.MESHKidney Transplantation-
dc.subject.MESHMale-
dc.subject.MESHMiddle Aged-
dc.subject.MESHMycophenolic Acid-
dc.subject.MESHProspective Studies-
dc.subject.MESHRepublic of Korea-
dc.subject.MESHTacrolimus-
dc.subject.MESHTreatment Outcome-
dc.titleClinical Study of Standard- vs Reduced-Dose Tacrolimus Combined With Generic Mycophenolate Mofetil in De Novo Kidney Transplantation: A Prospective Randomized Trial-
dc.typeArticle-
dc.identifier.pmid31898939-
dc.contributor.affiliatedAuthorBang, JB-
dc.contributor.affiliatedAuthorOh, CK-
dc.contributor.affiliatedAuthorLee, SH-
dc.type.localJournal Papers-
dc.identifier.doi10.1016/j.transproceed.2019.11.029-
dc.citation.titleTransplantation proceedings-
dc.citation.volume52-
dc.citation.number1-
dc.citation.date2020-
dc.citation.startPage133-
dc.citation.endPage139-
dc.identifier.bibliographicCitationTransplantation proceedings, 52(1). : 133-139, 2020-
dc.embargo.liftdate9999-12-31-
dc.embargo.terms9999-12-31-
dc.identifier.eissn1873-2623-
dc.relation.journalidJ000411345-
Appears in Collections:
Journal Papers > School of Medicine / Graduate School of Medicine > Surgery
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