PMID- 15848497
OWN - NLM
STAT- MEDLINE
DCOM- 20050926
LR  - 20181201
IS  - 0041-1345 (Print)
IS  - 0041-1345 (Linking)
VI  - 37
IP  - 2
DP  - 2005 Mar
TI  - 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.
PG  - 672-4
AB  - INTRODUCTION: Basiliximab is a monoclonal antibody directed to the interleukin-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.
FAU - Turconi, A
AU  - Turconi A
AD  - Hospital Garrahan, Buenos Aires, Argentina. aturconi@infovial.com.ar
FAU - Rilo, L Rodriguez
AU  - Rilo LR
FAU - Goldberg, J
AU  - Goldberg J
FAU - de Boccardo, G
AU  - de Boccardo G
FAU - Garsd, A
AU  - Garsd A
FAU - Otero, A
AU  - Otero A
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PL  - United States
TA  - Transplant Proc
JT  - Transplantation proceedings
JID - 0243532
RN  - 0 (Adrenal Cortex Hormones)
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Immunosuppressive Agents)
RN  - 0 (Recombinant Fusion Proteins)
RN  - 83HN0GTJ6D (Cyclosporine)
RN  - 9927MT646M (Basiliximab)
RN  - HU9DX48N0T (Mycophenolic Acid)
SB  - IM
MH  - Adrenal Cortex Hormones/therapeutic use
MH  - Antibodies, Monoclonal/*therapeutic use
MH  - Basiliximab
MH  - Biopsy
MH  - Cadaver
MH  - Child
MH  - Cyclosporine/therapeutic use
MH  - Drug Therapy, Combination
MH  - Female
MH  - Graft Rejection/*pathology
MH  - Histocompatibility Testing
MH  - Humans
MH  - Immunosuppressive Agents/*therapeutic use
MH  - Kidney Transplantation/*immunology
MH  - Living Donors
MH  - Male
MH  - Mycophenolic Acid/therapeutic use
MH  - Prospective Studies
MH  - Recombinant Fusion Proteins/*therapeutic use
MH  - Safety
MH  - Tissue Donors
EDAT- 2005/04/26 09:00
MHDA- 2005/09/27 09:00
CRDT- 2005/04/26 09:00
PHST- 2005/04/26 09:00 [pubmed]
PHST- 2005/09/27 09:00 [medline]
PHST- 2005/04/26 09:00 [entrez]
AID - S0041-1345(05)00138-7 [pii]
AID - 10.1016/j.transproceed.2005.02.022 [doi]
PST - ppublish
SO  - Transplant Proc. 2005 Mar;37(2):672-4. doi: 10.1016/j.transproceed.2005.02.022.