Open-label, multicenter study on the safety, tolerability, and efficacy of simulect in pediatric renal transplant recipients receiving triple therapy with cyclosporin, mycophenolate, and corticosteroids

A. Turconi, L. Rodriguez Rilo, J. Goldberg, G. De Boccardo, A. Garsd, A. Otero

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

Introduction. Basiliximab is a monoclonal antibody directed to theinterleukin-2 receptor. Several studies have demonstrated both its efficacy and safety. Even with the use of polyclonal antibodies in renal pediatric transplant recipients, the local incidence of steroid-resistant rejections has been close to 10% of the total incidence of acute rejection episodes (AREs). An open, multicenter prospective study was performed to assess the safety tolerability, and efficacy of induction with basiliximab in renal pediatric transplant patients receiving cyclosporine, mycophenolate, and steroids. Materials and Methods. Eighteen patients (8 boys) of mean age 11.9 ± 4.5 years and body weight 32 ± 15 kg received cadaveric (n = 7) or living (n = 11) donor grafts. Simulect was administered on days 0 and 4. Efficacy was assessed by the incidence of biopsy-proven acute rejection (BPAR). Safety assessment consisted of a description of the adverse events (AEs). Results. Six BPAR (Banff I and II) occurred in 5, (27.7%) children all of which were steroid responsive. Creatinine levels at day 7 and months 3, 6, and 12 were 1.6 ± 1.5 mg/dL, 1.0 ± 0.4 mg/dL, 1.0 ± 0.5 mg/dL, and 1.0 ± 0.4 mg/dL, respectively. Schwartz calculation at 12 months was 71 ± 15 mL/1.73 m2 AEs were hypertension (12), anemia (9), abdominal pain (8), metabolic acidosis (8), nausea (7), diarrhea (2), gingival hypertrophy (2), hirsutism (2), lymphocele (2), and infections (15). No deaths, graft losses, PTLDs, or malignancies were observed. Conclusions. No steroid-resistant AREs, were observed in this pediatric group using basiliximab. The Schwartz calculation at 12 months was 71 ± 15 mL/min/1.73 m2.

Original languageEnglish (US)
Pages (from-to)672-674
Number of pages3
JournalTransplantation Proceedings
Volume37
Issue number2
DOIs
StatePublished - Mar 2005
Externally publishedYes

Fingerprint

Cyclosporine
Multicenter Studies
Adrenal Cortex Hormones
Steroids
Pediatrics
Kidney
Safety
Transplants
Gingival Hypertrophy
Incidence
Lymphocele
Biopsy
Hirsutism
Therapeutics
Acidosis
Nausea
Abdominal Pain
Anemia
Diarrhea
Creatinine

ASJC Scopus subject areas

  • Surgery
  • Transplantation

Cite this

Open-label, multicenter study on the safety, tolerability, and efficacy of simulect in pediatric renal transplant recipients receiving triple therapy with cyclosporin, mycophenolate, and corticosteroids. / Turconi, A.; Rodriguez Rilo, L.; Goldberg, J.; De Boccardo, G.; Garsd, A.; Otero, A.

In: Transplantation Proceedings, Vol. 37, No. 2, 03.2005, p. 672-674.

Research output: Contribution to journalArticle

@article{4ef0979134494dc9a667be9ff955e4b2,
title = "Open-label, multicenter study on the safety, tolerability, and efficacy of simulect in pediatric renal transplant recipients receiving triple therapy with cyclosporin, mycophenolate, and corticosteroids",
abstract = "Introduction. Basiliximab is a monoclonal antibody directed to theinterleukin-2 receptor. Several studies have demonstrated both its efficacy and safety. Even with the use of polyclonal antibodies in renal pediatric transplant recipients, the local incidence of steroid-resistant rejections has been close to 10{\%} of the total incidence of acute rejection episodes (AREs). An open, multicenter prospective study was performed to assess the safety tolerability, and efficacy of induction with basiliximab in renal pediatric transplant patients receiving cyclosporine, mycophenolate, and steroids. Materials and Methods. Eighteen patients (8 boys) of mean age 11.9 ± 4.5 years and body weight 32 ± 15 kg received cadaveric (n = 7) or living (n = 11) donor grafts. Simulect was administered on days 0 and 4. Efficacy was assessed by the incidence of biopsy-proven acute rejection (BPAR). Safety assessment consisted of a description of the adverse events (AEs). Results. Six BPAR (Banff I and II) occurred in 5, (27.7{\%}) children all of which were steroid responsive. Creatinine levels at day 7 and months 3, 6, and 12 were 1.6 ± 1.5 mg/dL, 1.0 ± 0.4 mg/dL, 1.0 ± 0.5 mg/dL, and 1.0 ± 0.4 mg/dL, respectively. Schwartz calculation at 12 months was 71 ± 15 mL/1.73 m2 AEs were hypertension (12), anemia (9), abdominal pain (8), metabolic acidosis (8), nausea (7), diarrhea (2), gingival hypertrophy (2), hirsutism (2), lymphocele (2), and infections (15). No deaths, graft losses, PTLDs, or malignancies were observed. Conclusions. No steroid-resistant AREs, were observed in this pediatric group using basiliximab. The Schwartz calculation at 12 months was 71 ± 15 mL/min/1.73 m2.",
author = "A. Turconi and {Rodriguez Rilo}, L. and J. Goldberg and {De Boccardo}, G. and A. Garsd and A. Otero",
year = "2005",
month = "3",
doi = "10.1016/j.transproceed.2005.02.022",
language = "English (US)",
volume = "37",
pages = "672--674",
journal = "Transplantation Proceedings",
issn = "0041-1345",
publisher = "Elsevier USA",
number = "2",

}

TY - JOUR

T1 - Open-label, multicenter study on the safety, tolerability, and efficacy of simulect in pediatric renal transplant recipients receiving triple therapy with cyclosporin, mycophenolate, and corticosteroids

AU - Turconi, A.

AU - Rodriguez Rilo, L.

AU - Goldberg, J.

AU - De Boccardo, G.

AU - Garsd, A.

AU - Otero, A.

PY - 2005/3

Y1 - 2005/3

N2 - Introduction. Basiliximab is a monoclonal antibody directed to theinterleukin-2 receptor. Several studies have demonstrated both its efficacy and safety. Even with the use of polyclonal antibodies in renal pediatric transplant recipients, the local incidence of steroid-resistant rejections has been close to 10% of the total incidence of acute rejection episodes (AREs). An open, multicenter prospective study was performed to assess the safety tolerability, and efficacy of induction with basiliximab in renal pediatric transplant patients receiving cyclosporine, mycophenolate, and steroids. Materials and Methods. Eighteen patients (8 boys) of mean age 11.9 ± 4.5 years and body weight 32 ± 15 kg received cadaveric (n = 7) or living (n = 11) donor grafts. Simulect was administered on days 0 and 4. Efficacy was assessed by the incidence of biopsy-proven acute rejection (BPAR). Safety assessment consisted of a description of the adverse events (AEs). Results. Six BPAR (Banff I and II) occurred in 5, (27.7%) children all of which were steroid responsive. Creatinine levels at day 7 and months 3, 6, and 12 were 1.6 ± 1.5 mg/dL, 1.0 ± 0.4 mg/dL, 1.0 ± 0.5 mg/dL, and 1.0 ± 0.4 mg/dL, respectively. Schwartz calculation at 12 months was 71 ± 15 mL/1.73 m2 AEs were hypertension (12), anemia (9), abdominal pain (8), metabolic acidosis (8), nausea (7), diarrhea (2), gingival hypertrophy (2), hirsutism (2), lymphocele (2), and infections (15). No deaths, graft losses, PTLDs, or malignancies were observed. Conclusions. No steroid-resistant AREs, were observed in this pediatric group using basiliximab. The Schwartz calculation at 12 months was 71 ± 15 mL/min/1.73 m2.

AB - Introduction. Basiliximab is a monoclonal antibody directed to theinterleukin-2 receptor. Several studies have demonstrated both its efficacy and safety. Even with the use of polyclonal antibodies in renal pediatric transplant recipients, the local incidence of steroid-resistant rejections has been close to 10% of the total incidence of acute rejection episodes (AREs). An open, multicenter prospective study was performed to assess the safety tolerability, and efficacy of induction with basiliximab in renal pediatric transplant patients receiving cyclosporine, mycophenolate, and steroids. Materials and Methods. Eighteen patients (8 boys) of mean age 11.9 ± 4.5 years and body weight 32 ± 15 kg received cadaveric (n = 7) or living (n = 11) donor grafts. Simulect was administered on days 0 and 4. Efficacy was assessed by the incidence of biopsy-proven acute rejection (BPAR). Safety assessment consisted of a description of the adverse events (AEs). Results. Six BPAR (Banff I and II) occurred in 5, (27.7%) children all of which were steroid responsive. Creatinine levels at day 7 and months 3, 6, and 12 were 1.6 ± 1.5 mg/dL, 1.0 ± 0.4 mg/dL, 1.0 ± 0.5 mg/dL, and 1.0 ± 0.4 mg/dL, respectively. Schwartz calculation at 12 months was 71 ± 15 mL/1.73 m2 AEs were hypertension (12), anemia (9), abdominal pain (8), metabolic acidosis (8), nausea (7), diarrhea (2), gingival hypertrophy (2), hirsutism (2), lymphocele (2), and infections (15). No deaths, graft losses, PTLDs, or malignancies were observed. Conclusions. No steroid-resistant AREs, were observed in this pediatric group using basiliximab. The Schwartz calculation at 12 months was 71 ± 15 mL/min/1.73 m2.

UR - http://www.scopus.com/inward/record.url?scp=17844372739&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=17844372739&partnerID=8YFLogxK

U2 - 10.1016/j.transproceed.2005.02.022

DO - 10.1016/j.transproceed.2005.02.022

M3 - Article

VL - 37

SP - 672

EP - 674

JO - Transplantation Proceedings

JF - Transplantation Proceedings

SN - 0041-1345

IS - 2

ER -