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A Prospective, Randomized, Multicenter Trial of Tacrolimus‐Based Therapy with or without Basiliximab in Pediatric Renal Transplantation
Author(s) -
Grenda R.,
Watson A.,
Vondrak K.,
Webb N. J. A.,
Beattie J.,
Fitzpatrick M.,
Saleem M. A.,
Trompeter R.,
Milford D. V.,
Moghal N. E.,
Hughes D.,
Perner F.,
Friman S.,
Van DammeLombaerts R.,
Janssen F.
Publication year - 2006
Publication title -
american journal of transplantation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.89
H-Index - 188
eISSN - 1600-6143
pISSN - 1600-6135
DOI - 10.1111/j.1600-6143.2006.01367.x
Subject(s) - basiliximab , medicine , tacrolimus , transplantation , azathioprine , gastroenterology , urology , regimen , renal function , creatinine , multicenter trial , immunosuppression , surgery , randomized controlled trial , multicenter study , disease
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 μmol/L in the TAS and 91 μmol/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.