Efficacy and tolerability of interleukin‐2 receptor blockade with basiliximab in pediatric renal transplant recipients

Vester, Udo; Kranz, Birgitta; Testa, Giuliano; Malagó, Massimo; Beelen, Dietrich W.; Broelsch, Christoph E.; Hoyer, Peter F.

doi:10.1034/j.1399-3046.2001.005004297.x

Cited by 34 publications

(20 citation statements)

References 13 publications

(12 reference statements)

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“…Most patients were treated according to the local immunosuppressive protocol consisting of basilximab, cyclosporine A, and prednisone as described elsewhere (15).…”

Section: Methodsmentioning

confidence: 99%

Outcome after kidney transplantation in children with thrombotic risk factors

Kranz

Vester

Nadalin

et al. 2006

Pediatric Transplantation

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“…Most patients were treated according to the local immunosuppressive protocol consisting of basilximab, cyclosporine A, and prednisone as described elsewhere (15).…”

Section: Methodsmentioning

confidence: 99%

Outcome after kidney transplantation in children with thrombotic risk factors

Kranz

Vester

Nadalin

et al. 2006

Pediatric Transplantation

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“…The large majority of these studies investigated recipients receiving ciclosporin as the calcineurin inhibitor; relatively few studies have investigated the addition of an interleukin-2 receptor to a tacrolimus-based immunosuppressive regimen. In children, the North American Pediatric Renal Trials and Collaborative Studies (NAPRTCS) registry has reported that there is an increase in acute rejection in children who did not receive an interleukin-2 receptor antagonist [3], and a number of other reports have indicated that these agents appear to be safe and efficacious [4][5][6][7].…”

Section: Introductionmentioning

confidence: 97%

Multicentre prospective randomised trial of tacrolimus, azathioprine and prednisolone with or without basiliximab: two-year follow-up data

et al. 2009

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A total of 192 children and adolescents undergoing renal transplantation were randomly chosen to receive tacrolimus, azathioprine and corticosteroids (TAS, n = 93) or tacrolimus, azathioprine, corticosteroids and two doses of basiliximab (TAS + B, n = 99). Six-month outcome data have previously been reported; this manuscript reports the 2-year data. Complete 2-year data were available on 164 (85.4%) of the original 192 patients. There was a single death in the TAS arm. Kaplan-Meier estimates of survival free of graft loss at 2 years were 94.9% in the TAS + B arm and 89.6% in the TAS arm [hazard ratio (HR) 0.52; 95% confidence interval (CI) 0.17 to 1.54, P = 0.23]. Estimates of survival free from rejection at 2 years were 75.2% in the TAS + B arm and 68.7% in the TAS arm (HR 0.81; 95% CI 0.46 to 1.40, P = 0.44). The mean estimated glomerular filtration rate (GFR) at 2 years, was 65.8 ml/min per 1.73 m(2) body surface area in the TAS arm and 66.7 ml/min per 1.73 m(2) in the TAS + B arm (P = 0.78). Blood pressure and cholesterol levels were similar in the two arms, and there was no evidence of a difference in the incidence of infection or malignancy. These data provide further evidence of a lack of benefit associated with the addition of basiliximab to a TAS regimen for European paediatric renal transplant recipients at low immunological risk.

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“…In pediatric renal transplantation, isolated reports have demonstrated that induction therapy with basiliximab combined with calcineurin inhibitors is safe and efficacious (10)(11)(12)(13). However, so far there have been no randomized, controlled, prospective trials in pediatric patients.…”

Section: Introductionmentioning

confidence: 99%

A Prospective, Randomized, Multicenter Trial of Tacrolimus-Based Therapy with or without Basiliximab in Pediatric Renal Transplantation

Grenda

Watson

Vondrák

et al. 2006

American Journal of Transplantation

107

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In a 6-month, multicenter, randomized, controlled, open-label, parallel-group trial, we investigated the efficacy and safety of adding basiliximab to a standard tacrolimus-based regimen in pediatric renal transplant recipients. Patients <18 years received tacrolimus/azathioprine/steroids (TAS, n = 93) or tacrolimus/azathioprine/steroids/basiliximab (TAS + B, n = 99). Target tacrolimus levels were 10-20 ng/mL between days 0-21 and 5-15 ng/mL thereafter. Steroid dosing was identical in both groups. Basiliximab was administered at 10 mg (patients <40 kg) or 20 mg (patients ≥40 kg) within 4 h of reperfusion; the same dose was repeated on day 4. Biopsy-proven acute rejection rates were 20.4% (TAS) and 19.2% (TAS + B); steroid-resistant acute rejection rates were 3.2% and 3.0%, respectively. Patient survival was 100%; graft survival rates were 95% in both arms. The nature and incidence of adverse events were similar in both arms except toxic nephropathy and abdominal pain, which were significantly higher in the TAS + B arm (14.1% vs. 4.3%; p = 0.03 and 11.1% vs. 2.2%; p = 0.02; respectively). Median serum creatinine concentrations at 6 months were 86 lmol/L in the TAS and 91 lmol/L in the TAS + B arm; glomerular filtration rate was 79.4 and 77.6 (mL/min/1.73 m 2 ), respectively. Adding basiliximab to a tacrolimus-based regimen is safe in pediatric patients, but does not improve clinical efficacy.

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Efficacy and tolerability of interleukin‐2 receptor blockade with basiliximab in pediatric renal transplant recipients

Cited by 34 publications

References 13 publications

Outcome after kidney transplantation in children with thrombotic risk factors

Outcome after kidney transplantation in children with thrombotic risk factors

Multicentre prospective randomised trial of tacrolimus, azathioprine and prednisolone with or without basiliximab: two-year follow-up data

A Prospective, Randomized, Multicenter Trial of Tacrolimus-Based Therapy with or without Basiliximab in Pediatric Renal Transplantation

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