Details

Autor(en) / Beteiligte

• 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, Y.J.
• Jiang, H.
• Lee, H.
• Park, S.-K.

Titel

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

Ist Teil von

• Transplantation proceedings, 2019-04, Vol.51 (3), p.749-760

Ort / Verlag

United States: Elsevier Inc

Erscheinungsjahr

2019

Quelle

Alma/SFX Local Collection

Beschreibungen/Notizen

• 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. 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. 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. Renal function was maintained following conversion from cyclosporine to PR-T, irrespective of corticosteroid regimen; PR-T enables reduced corticosteroid dosage. •Prolonged-release tacrolimus dose was similar in the reduced- vs standard-dose group post conversion from cyclosporine.•Similar, stable prolonged-release tacrolimus trough blood levels were observed between treatment groups.•No significant difference in estimated glomerular filtration rate was seen between treatment groups at baseline and week 24.•Most patients (>70%) considered prolonged-release tacrolimus more convenient than cyclosporine.•Most adverse events in both treatment groups were mild or moderate in severity.