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document
Induction versus noninduction in renal transplant recipients with tacrolimus-based immunosuppression . BACKGROUND The aim of this study was to compare the efficacy and safety of induction treatment with antithymocyte globulins ( ATG ) followed by tacrolimus therapy with immediate tacrolimus therapy in renal transplant recipients . METHODS This 12-month , open , prospective study was conducted in 15 centers in France and 1 center in Belgium ; 309 patients were randomized to receive either induction therapy with ATG ( n=151 ) followed by initiation of tacrolimus on day 9 or immediate tacrolimus-based triple therapy ( n=158 ) . In both study arms , the initial daily tacrolimus dose was 0.2 mg/kg . Steroid boluses were given in the first 2 days and tapered thereafter from 20 mg/day to 5 mg/day . Azathioprine was administered at 1-2 mg/kg per day . RESULTS At month 12 , biopsy-confirmed acute rejections were reported for 15.2 % ( induction ) and 30.4 % ( noninduction ) of patients ( P=0.001 ) . The incidence of steroid-sensitive acute rejections was 7.9 % ( induction ) and 22.2 % ( noninduction ) ( P=0.001 ) . Steroid-resistant acute rejections were reported for 8.6 % ( induction ) and 8.9 % ( noninduction ) of patients . A total of nine patients died . Patient survival and graft survival at month 12 was similar in both treatment groups ( 97.4 % vs. 96.8 % and 92.1 % vs. 91.1 % , respectively ) . Statistically significant differences in the incidence of adverse events were found for cytomegalovirus ( CMV ) infection ( induction , 32.5 % vs. noninduction , 19.0 % , P=0.009 ) , leukopenia ( 37.3 % vs. 9.5 % , P < 0.001 ) , fever ( 25.2 % vs. 10.1 % , P=0.001 ) , herpes simplex ( 17.9 % vs. 5.7 % , P=0.001 ) , and thrombocytopenia ( 11.3 % vs. 3.2 % , P=0.007 ) . In the induction group , serum sickness was observed in 10.6 % of patients . The incidence of new onset diabetes mellitus was 3.4 % ( induction ) and 4.5 % ( noninduction ) . CONCLUSION Low incidences of acute rejection were found in both treatment arms . Induction treatment with ATG has the advantage of a lower incidence of acute rejection , but it significantly increases adverse events , particularly CMV infection .
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Intervention_Pharmacological
noninduction
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Intervention_Pharmacological
antithymocyte globulins ( ATG )
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Intervention_Pharmacological
tacrolimus
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Intervention_Pharmacological
induction therapy with ATG
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Intervention_Pharmacological
tacrolimus
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Intervention_Pharmacological
tacrolimus-based triple therapy
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Intervention_Pharmacological
tacrolimus
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Intervention_Pharmacological
Steroid boluses
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Intervention_Pharmacological
Azathioprine
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Intervention_Pharmacological
ATG
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Outcome_Other
efficacy and safety
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Outcome_Physical
biopsy-confirmed acute rejections
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Outcome_Physical
incidence of steroid-sensitive acute rejections
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Outcome_Physical
Steroid-resistant acute rejections
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Outcome_Mortality
died . Patient survival and graft survival
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Outcome_Adverse-effects
incidence of adverse events
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Outcome_Adverse-effects
cytomegalovirus ( CMV ) infection
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Outcome_Adverse-effects
leukopenia
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Outcome_Adverse-effects
fever
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Outcome_Adverse-effects
herpes simplex
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Outcome_Adverse-effects
thrombocytopenia
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Outcome_Physical
serum sickness
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Outcome_Physical
new onset diabetes mellitus
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Outcome_Adverse-effects
adverse events
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Participant_Condition
renal transplant recipients with tacrolimus-based immunosuppression
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Participant_Condition
renal transplant recipients
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Participant_Sample-size
309 patients