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A prospective, rand...
A prospective, randomized, multicenter trial of tacrolimus-based therapy with or without basiliximab in pediatric renal transplantation
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Grenda, R. (author)
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Watson, A. (author)
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Vondrak, K. (author)
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Webb, N. J. (author)
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Beattie, J. (author)
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Fitzpatrick, M. (author)
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Saleem, M. A. (author)
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Trompeter, R. (author)
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Milford, D. V. (author)
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Moghal, N. E. (author)
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Hughes, D. (author)
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Perner, F. (author)
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- Friman, Styrbjörn, 1948 (author)
- Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper,Institute of Clinical Sciences
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Van Damme-Lombaerts, R. (author)
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Janssen, F. (author)
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(creator_code:org_t)
- Elsevier BV, 2006
- 2006
- English.
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In: American journal of transplantation. - : Elsevier BV. - 1600-6135. ; 6:7, s. 1666-72
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https://doi.org/10.1...
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Abstract
Subject headings
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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 > 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.
Keyword
- Adolescent
- Antibodies
- Monoclonal/adverse effects/*pharmacology
- Biopsy
- Child
- Child
- Preschool
- Female
- Follow-Up Studies
- Graft Rejection
- Graft Survival/drug effects
- Humans
- *Kidney Transplantation
- Male
- Recombinant Fusion Proteins/adverse effects/*pharmacology
- Tacrolimus/adverse effects/blood/*pharmacology
Publication and Content Type
- ref (subject category)
- art (subject category)
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- By the author/editor
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Grenda, R.
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Watson, A.
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Vondrak, K.
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Webb, N. J.
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Beattie, J.
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Fitzpatrick, M.
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show more...
-
Saleem, M. A.
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Trompeter, R.
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Milford, D. V.
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Moghal, N. E.
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Hughes, D.
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Perner, F.
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Friman, Styrbjör ...
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Van Damme-Lombae ...
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Janssen, F.
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show less...
- Articles in the publication
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American journal ...
- By the university
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University of Gothenburg