Randomized, Open-Label, Phase IV, Korean Study of Kidney Transplant Patients Converting From Cyclosporine to Prolonged-Release Tacrolimus Plus Standard- or Reduced-Dose Corticosteroids
| Autor: | B.C. Shin, S.W. Kim, H. Jiang, Jung-Shin Lee, Chan-Duck Kim, Sik Lee, H. Lee, K.W. Lee, Beom Seok Kim, Y.J. Kwon, D.R. Lee, Dong-Wan Chae, Y.H. Kim, Jaeseok Yang, S.H. Lee, S.Y. Han, C.H. Baek, S.-K. Park, J.M. Kong |
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| Rok vydání: | 2019 |
| Předmět: |
Adult
Graft Rejection Male medicine.medical_specialty medicine.drug_class Urology Renal function Tacrolimus law.invention Randomized controlled trial Adrenal Cortex Hormones law Republic of Korea medicine Clinical endpoint Humans Adverse effect Kidney transplantation Immunosuppression Therapy Transplantation business.industry Middle Aged medicine.disease Kidney Transplantation Transplant Recipients Regimen Patient Satisfaction Research Design Delayed-Action Preparations Cyclosporine Corticosteroid Female Surgery business Immunosuppressive Agents Glomerular Filtration Rate |
| Zdroj: | Transplantation Proceedings. 51:749-760 |
| ISSN: | 0041-1345 |
| DOI: | 10.1016/j.transproceed.2019.01.057 |
| Popis: | 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 m2 (P = .1567) and +3.4 ± 10.6 mL/min/1.73 m2 (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. |
| Databáze: | OpenAIRE |
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