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

doi:10.1007/s00467-001-0795-9

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

Fondazione IRCCS Ca' Granda- Ospedale Maggiore Policlinico

Research output: Contribution to journal › Article › peer-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 language	English
Pages (from-to)	141-149
Number of pages	9
Journal	Pediatric Nephrology
Volume	17
Issue number	3
DOIs	https://doi.org/10.1007/s00467-001-0795-9
Publication status	Published - 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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10.1007/s00467-001-0795-9

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Trompeter, R., Filler, G., Webb, N. J. A., Watson, A. R., Milford, D. V., Tyden, G., Grenda, R., Janda, J., Hughes, D., Ehrich, J. H. H., Klare, B., Zacchello, G., Brekke, I. B., McGraw, M., Perner, F., Ghio, L., Balzar, E., Friman, S., Gusmano, R., & Stolpe, J. (2002). Randomized trial of tracolimus versus cyclosporin microemulsion in renal transplantation. Pediatric Nephrology, 17(3), 141-149. https://doi.org/10.1007/s00467-001-0795-9

Randomized trial of tracolimus versus cyclosporin microemulsion in renal transplantation. / Trompeter, Richard; Filler, Guido; Webb, Nicholas J A; Watson, Alan R.; Milford, David V.; Tyden, Gunnar; Grenda, Ryszard; Janda, Jan; Hughes, David; Ehrich, Jochen H H; Klare, Bernd; Zacchello, Graziella; Brekke, Inge Bjorn; McGraw, Mary; Perner, Ferenc; Ghio, Lucian; Balzar, Egon; Friman, Styrbjörn; Gusmano, Rosanna; Stolpe, Jochen.

In: Pediatric Nephrology, Vol. 17, No. 3, 2002, p. 141-149.

Research output: Contribution to journal › Article › peer-review

Trompeter, R, Filler, G, Webb, NJA, Watson, AR, Milford, DV, Tyden, G, Grenda, R, Janda, J, Hughes, D, Ehrich, JHH, Klare, B, Zacchello, G, Brekke, IB, McGraw, M, Perner, F, Ghio, L, Balzar, E, Friman, S, Gusmano, R & Stolpe, J 2002, 'Randomized trial of tracolimus versus cyclosporin microemulsion in renal transplantation', Pediatric Nephrology, vol. 17, no. 3, pp. 141-149. https://doi.org/10.1007/s00467-001-0795-9

Trompeter, Richard ; Filler, Guido ; Webb, Nicholas J A ; Watson, Alan R. ; Milford, David V. ; Tyden, Gunnar ; Grenda, Ryszard ; Janda, Jan ; Hughes, David ; Ehrich, Jochen H H ; Klare, Bernd ; Zacchello, Graziella ; Brekke, Inge Bjorn ; McGraw, Mary ; Perner, Ferenc ; Ghio, Lucian ; Balzar, Egon ; Friman, Styrbjörn ; Gusmano, Rosanna ; Stolpe, Jochen. / Randomized trial of tracolimus versus cyclosporin microemulsion in renal transplantation. In: Pediatric Nephrology. 2002 ; Vol. 17, No. 3. pp. 141-149.

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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.",

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AU - Janda, Jan

AU - Hughes, David

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Randomized trial of tracolimus versus cyclosporin microemulsion in renal transplantation

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Keywords

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