Randomized trial of tracolimus versus cyclosporin microemulsion in renal transplantation

Richard Trompeter, Guido Filler, Nicholas J A Webb, Alan R. Watson, David V. Milford, Gunnar Tyden, Ryszard Grenda, Jan Janda, David Hughes, Jochen H H Ehrich, Bernd Klare, Graziella Zacchello, Inge Bjorn Brekke, Mary McGraw, Ferenc Perner, Lucian Ghio, Egon Balzar, Styrbjörn Friman, Rosanna Gusmano, Jochen Stolpe

Research output: Contribution to journalArticlepeer-review

Abstract

This study was undertaken to compare the efficacy and safety of tacrolimus (Tac) with the microemulsion formulation of cyclosporin (CyA) in children undergoing renal transplantation. A 6-month, randomized, prospective, open, parallel group study with an open extension phase was conducted in 18 centers from nine European countries. In total, 196 pediatric patients (2, n=84) than in the CyA group (56±21 ml/min per 1.73 m2, n=74, P=0.03). The most frequent adverse events during the first 6 months were hypertension (68.9% vs. 61.3%), hypomagnesemia (34.0% vs. 12.9%, P=0.001), and urinary tract infection (29.1% vs. 33.3%). Statistically significant differences (P30 days) insulin use was 3.0% (Tac) and 2.2% (CyA). Post-transplant lymphoproliferative disease was observed in 1 patient in the Tac group and 2 patients in the CyA group. In conclusion, Tac was significantly more effective than CyA microemulsion in preventing acute rejection after renal transplantation in a pediatric population. The overall safety profiles of the two regimens were comparable.

Original languageEnglish
Pages (from-to)141-149
Number of pages9
JournalPediatric Nephrology
Volume17
Issue number3
DOIs
Publication statusPublished - 2002

Keywords

  • Acute rejection
  • Cyclosporin microemulsion
  • Graft survival
  • Pediatric renal transplant
  • Tacrolimus

ASJC Scopus subject areas

  • Nephrology
  • Pediatrics, Perinatology, and Child Health

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