A prospective, randomized, multicenter trial of tacrolimus-based therapy with or without basiliximab in pediatric renal transplantation.
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 > or = 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 micromol/L in the TAS and 91 micromol/L in the TAS + B arm; glomerular filtration rate was 79.4 and 77.6 (mL/min/1.73 m2), respectively. Adding basiliximab to a tacrolimus-based regimen is safe in pediatric patients, but does not improve clinical efficacy.
Grenda
R
R
Department of Nephrology and Kidney Transplantation, Children's Memorial Health Institute, Warsaw, Poland. grenda@czd.waw.pl
Watson
A
A
Vondrak
K
K
Webb
N J A
NJ
Beattie
J
J
Fitzpatrick
M
M
Saleem
M A
MA
Trompeter
R
R
Milford
D V
DV
Moghal
N E
NE
Hughes
D
D
Perner
F
F
Friman
S
S
Van Damme-Lombaerts
R
R
Janssen
F
F
D000293:Adolescent; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000494:pharmacology*; D000077552:Basiliximab; D001706:Biopsy; D002648:Child; D002675:Child, Preschool; D005260:Female; D005500:Follow-Up Studies; D006084:Graft Rejection; D006085:Graft Survival / Q000187:drug effects; D006801:Humans; D016030:Kidney Transplantation; D008297:Male; D011993:Recombinant Fusion Proteins / Q000009:adverse effects / Q000494:pharmacology*; D016559:Tacrolimus / Q000009:adverse effects / Q000097:blood / Q000494:pharmacology*
D000911:Antibodies, Monoclonal; D011993:Recombinant Fusion Proteins; D000077552:Basiliximab; D016559:Tacrolimus