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

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 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.

Immunosuppressive therapy for kidney transplantation in children and adolescents: systematic review and economic evaluation

“…In all three studies, 73,75,77 it was not clear whether or not all reported outcomes were the same as those in the trial protocol and the reporting of loss to follow-up, withdrawals and dropouts was also not clearly reported.…”

“…In summary, three RCTs (published in seven papers [73][74][75][76][77][78][79] and one abstract 72 ) were found eligible and are included in this review (Table 10). • Abstract, n = 332…”

“…Although RCTs in mixed populations were identified, none included subgroup analysis by age -providing separate results for children/adolescents and adultsand were therefore excluded from the review (a list of these records can be found in Appendix 2, Table 136). Three RCTs (published in one abstract 72 and seven papers [73][74][75][76][77][78][79] ) met the inclusion criteria.…”

“…75,77 Concealment of allocation: the method of concealment of allocation was clearly reported in only one trial 77 and unclear in the other two trials.…”

“…73,75,77 Treatment allocation masked from participants: the method was clearly stated and adequate in only one trial. 73 In the other two trials, participants were not blinded to treatment allocation.…”