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A prospective, randomized, multicenter trial of tacrolimus-based therapy with or without basiliximab in pediatric renal transplantation

Lookup NU author(s): Professor Mushtaq Saleem, Dr Nadeem Moghal

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Abstract

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 mu mol/L in the TAS and 91 mu mol/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.

Publication metadata

Author(s): Grenda R, Watson A, Vondrak K, Webb NJA, Beattie J, Fitzpatrick M, Saleem MA, Trompeter R, Milford DV, Moghal NE, Hughes D, Perner F, Friman S, Van Damme-Lombaerts R, Janssen F

Publication type: Article

Publication status: Published

Journal: American Journal of Transplantation

Year: 2006

Volume: 6

Issue: 7

Pages: 1666-1672

ISSN (print): 1600-6135

ISSN (electronic): 1600-6143

Publisher: Wiley-Blackwell

URL: http://dx.doi.org/10.1111/j.1600-6143.2006.01367.x

DOI: 10.1111/j.1600-6143.2006.01367.x

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