Conversion to tacrolimus once-daily from ciclosporin in stable kidney transplant recipients: A multicenter study

Lionel Rostaing, Ana Sánchez-Fructuoso, Antonio Franco, MacIej Glyda, Dirk R. Kuypers, J. Járay

Research output: Contribution to journalArticle

15 Citations (Scopus)

Abstract

This 24-week, open, single-arm, prospective, multicenter study evaluated the effects of conversion from ciclosporin to Tacrolimus QD in adult kidney transplant patients. Stable patients receiving ciclosporin were converted to Tacrolimus QD at 0.1 mg/kg/day. Relative change in renal function (primary endpoint) was assessed using estimated creatinine clearance (eCrCl) with a noninferiority margin set at -10%. A total of 346 patients were enrolled; and 301 patients were treated per protocol (PPS) in the hyperlipidemia (n = 42), hypertrichosis (n = 106), hypertension (n = 77) and gingival hyperplasia (n = 76) groups. Relative change in eCrCl was -0.6% in all PPS patients (95% CI, -2.2; 0.9) and -5.3% in the hyperlipidemia (CI, -9.59; -0.97), 0.9% in the hypertrichosis (CI, -2.59; 4.45), -0.1% in the hypertension (CI, -3.8; 3.68), and -1% in the gingival hyperplasia groups (CI, -4.63; 2.65) (PPS), meeting noninferiority criteria. There was no acute rejection. Decreases in serum lipids and blood pressure were moderate but without meaningful change in the number of treatment medications. Substantial decreases in severity of ciclosporin-related cosmetic side effects were evident from investigator and patient self-report of symptoms. Renal function remained stable after conversion to Tacrolimus QD. The effect of conversion on cardiovascular parameters was not clinically meaningful, however, marked improvement in ciclosporin-related cosmetic side effects was observed.

Original languageEnglish
Pages (from-to)391-400
Number of pages10
JournalTransplant International
Volume25
Issue number4
DOIs
Publication statusPublished - Apr 2012

Fingerprint

Tacrolimus
Cyclosporine
Multicenter Studies
Kidney
Gingival Hyperplasia
Hypertrichosis
Hyperlipidemias
Cosmetics
Creatinine
Hypertension
Self Report
Transplant Recipients
Research Personnel
Prospective Studies
Blood Pressure
Transplants
Lipids
Serum

Keywords

  • gingival hyperplasia
  • hirsutism
  • hyperlipidemia
  • kidney function
  • kidney transplantation
  • tacrolimus once daily

ASJC Scopus subject areas

  • Transplantation

Cite this

Conversion to tacrolimus once-daily from ciclosporin in stable kidney transplant recipients : A multicenter study. / Rostaing, Lionel; Sánchez-Fructuoso, Ana; Franco, Antonio; Glyda, MacIej; Kuypers, Dirk R.; Járay, J.

In: Transplant International, Vol. 25, No. 4, 04.2012, p. 391-400.

Research output: Contribution to journalArticle

Rostaing, Lionel ; Sánchez-Fructuoso, Ana ; Franco, Antonio ; Glyda, MacIej ; Kuypers, Dirk R. ; Járay, J. / Conversion to tacrolimus once-daily from ciclosporin in stable kidney transplant recipients : A multicenter study. In: Transplant International. 2012 ; Vol. 25, No. 4. pp. 391-400.
@article{2beb20f80a5541f29a86ecfee841d1d3,
title = "Conversion to tacrolimus once-daily from ciclosporin in stable kidney transplant recipients: A multicenter study",
abstract = "This 24-week, open, single-arm, prospective, multicenter study evaluated the effects of conversion from ciclosporin to Tacrolimus QD in adult kidney transplant patients. Stable patients receiving ciclosporin were converted to Tacrolimus QD at 0.1 mg/kg/day. Relative change in renal function (primary endpoint) was assessed using estimated creatinine clearance (eCrCl) with a noninferiority margin set at -10{\%}. A total of 346 patients were enrolled; and 301 patients were treated per protocol (PPS) in the hyperlipidemia (n = 42), hypertrichosis (n = 106), hypertension (n = 77) and gingival hyperplasia (n = 76) groups. Relative change in eCrCl was -0.6{\%} in all PPS patients (95{\%} CI, -2.2; 0.9) and -5.3{\%} in the hyperlipidemia (CI, -9.59; -0.97), 0.9{\%} in the hypertrichosis (CI, -2.59; 4.45), -0.1{\%} in the hypertension (CI, -3.8; 3.68), and -1{\%} in the gingival hyperplasia groups (CI, -4.63; 2.65) (PPS), meeting noninferiority criteria. There was no acute rejection. Decreases in serum lipids and blood pressure were moderate but without meaningful change in the number of treatment medications. Substantial decreases in severity of ciclosporin-related cosmetic side effects were evident from investigator and patient self-report of symptoms. Renal function remained stable after conversion to Tacrolimus QD. The effect of conversion on cardiovascular parameters was not clinically meaningful, however, marked improvement in ciclosporin-related cosmetic side effects was observed.",
keywords = "gingival hyperplasia, hirsutism, hyperlipidemia, kidney function, kidney transplantation, tacrolimus once daily",
author = "Lionel Rostaing and Ana S{\'a}nchez-Fructuoso and Antonio Franco and MacIej Glyda and Kuypers, {Dirk R.} and J. J{\'a}ray",
year = "2012",
month = "4",
doi = "10.1111/j.1432-2277.2011.01409.x",
language = "English",
volume = "25",
pages = "391--400",
journal = "Transplant International",
issn = "0934-0874",
publisher = "Wiley-Blackwell",
number = "4",

}

TY - JOUR

T1 - Conversion to tacrolimus once-daily from ciclosporin in stable kidney transplant recipients

T2 - A multicenter study

AU - Rostaing, Lionel

AU - Sánchez-Fructuoso, Ana

AU - Franco, Antonio

AU - Glyda, MacIej

AU - Kuypers, Dirk R.

AU - Járay, J.

PY - 2012/4

Y1 - 2012/4

N2 - This 24-week, open, single-arm, prospective, multicenter study evaluated the effects of conversion from ciclosporin to Tacrolimus QD in adult kidney transplant patients. Stable patients receiving ciclosporin were converted to Tacrolimus QD at 0.1 mg/kg/day. Relative change in renal function (primary endpoint) was assessed using estimated creatinine clearance (eCrCl) with a noninferiority margin set at -10%. A total of 346 patients were enrolled; and 301 patients were treated per protocol (PPS) in the hyperlipidemia (n = 42), hypertrichosis (n = 106), hypertension (n = 77) and gingival hyperplasia (n = 76) groups. Relative change in eCrCl was -0.6% in all PPS patients (95% CI, -2.2; 0.9) and -5.3% in the hyperlipidemia (CI, -9.59; -0.97), 0.9% in the hypertrichosis (CI, -2.59; 4.45), -0.1% in the hypertension (CI, -3.8; 3.68), and -1% in the gingival hyperplasia groups (CI, -4.63; 2.65) (PPS), meeting noninferiority criteria. There was no acute rejection. Decreases in serum lipids and blood pressure were moderate but without meaningful change in the number of treatment medications. Substantial decreases in severity of ciclosporin-related cosmetic side effects were evident from investigator and patient self-report of symptoms. Renal function remained stable after conversion to Tacrolimus QD. The effect of conversion on cardiovascular parameters was not clinically meaningful, however, marked improvement in ciclosporin-related cosmetic side effects was observed.

AB - This 24-week, open, single-arm, prospective, multicenter study evaluated the effects of conversion from ciclosporin to Tacrolimus QD in adult kidney transplant patients. Stable patients receiving ciclosporin were converted to Tacrolimus QD at 0.1 mg/kg/day. Relative change in renal function (primary endpoint) was assessed using estimated creatinine clearance (eCrCl) with a noninferiority margin set at -10%. A total of 346 patients were enrolled; and 301 patients were treated per protocol (PPS) in the hyperlipidemia (n = 42), hypertrichosis (n = 106), hypertension (n = 77) and gingival hyperplasia (n = 76) groups. Relative change in eCrCl was -0.6% in all PPS patients (95% CI, -2.2; 0.9) and -5.3% in the hyperlipidemia (CI, -9.59; -0.97), 0.9% in the hypertrichosis (CI, -2.59; 4.45), -0.1% in the hypertension (CI, -3.8; 3.68), and -1% in the gingival hyperplasia groups (CI, -4.63; 2.65) (PPS), meeting noninferiority criteria. There was no acute rejection. Decreases in serum lipids and blood pressure were moderate but without meaningful change in the number of treatment medications. Substantial decreases in severity of ciclosporin-related cosmetic side effects were evident from investigator and patient self-report of symptoms. Renal function remained stable after conversion to Tacrolimus QD. The effect of conversion on cardiovascular parameters was not clinically meaningful, however, marked improvement in ciclosporin-related cosmetic side effects was observed.

KW - gingival hyperplasia

KW - hirsutism

KW - hyperlipidemia

KW - kidney function

KW - kidney transplantation

KW - tacrolimus once daily

UR - http://www.scopus.com/inward/record.url?scp=84858442644&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84858442644&partnerID=8YFLogxK

U2 - 10.1111/j.1432-2277.2011.01409.x

DO - 10.1111/j.1432-2277.2011.01409.x

M3 - Article

C2 - 22211928

AN - SCOPUS:84858442644

VL - 25

SP - 391

EP - 400

JO - Transplant International

JF - Transplant International

SN - 0934-0874

IS - 4

ER -