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document
Cyclosporin versus cyclophosphamide for patients with steroid-dependent and frequently relapsing idiopathic nephrotic syndrome : a multicentre randomized controlled trial . OBJECTIVE To compare the efficacy ( maintenance of remission ) , safety and tolerability of cyclosporin ( CsA ) with those of cyclophosphamide in patients with steroid-dependent or frequently relapsing nephrotic syndrome ( NS ) . DESIGN Open , prospective , randomized , multicentre , controlled study for parallel groups , stratified for adults and children . The setting was in nephrological departments in Italy . SUBJECTS AND INTERVENTIONS Seventy-three patients with steroid-sensitive idiopathic NS admitted to the study were randomly assigned to cyclophosphamide ( 2.5 mg/kg/day ) for 8 weeks or CsA ( 5 mg/kg/day in adults , 6 mg/kg/day in children ) for 9 months , tapered off by 25 % every month until complete discontinuation at month 12 . Seven patients lost to follow up were not considered in the analysis . The remaining 66 patients were followed up for 3-24 months after randomization . MAIN OUTCOME MEASURES Relapse-free survival ; number of N.S . relapses/patient/year ; cumulative dose of prednisone/patient ; laboratory investigations ( kidney and liver functions , haematological parameters ) ; incidence of adverse events . RESULTS At month 9 , 26 of 35 CsA-treated patients were still in complete remission and a further five patients were in partial remission ; 18 of 28 cyclophosphamide-treated patients were in complete remission , and one in partial remission ( P = NS ) . No difference between adults and children was seen with either treatment . The risk of relapse was similar between frequent relapsers ( 19 of 22 ) and steroid-dependent patients ( 8 of 14 ) given CsA , and those given cyclophosphamide ( 5 of 15 and 6 of 15 ) . The mean number of relapses per year and the mean dose of prednisone per year were significantly less ( P < 0.001 ) in both groups for the experimental year than for the year before randomization . At 2 years , 25 % of the patients given CsA ( 50 % adults and 20 % children ) and 63 % of those given cyclophosphamide ( 40 % adults and 68 % children ) had not had any relapse of NS . Tolerance to the two drugs was generally good . The CsA-related side-effects were mild and disappeared after drug discontinuation . CONCLUSIONS This study shows that both treatments are effective and well tolerated ; more patients given cyclophosphamide had stable remissions .
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Intervention_Pharmacological
Cyclosporin
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Intervention_Pharmacological
cyclophosphamide
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Intervention_Pharmacological
cyclosporin ( CsA )
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Intervention_Pharmacological
cyclophosphamide
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Intervention_Pharmacological
cyclophosphamide
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Intervention_Pharmacological
CsA
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Intervention_Pharmacological
cyclophosphamide-treated
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Intervention_Pharmacological
cyclophosphamide
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Intervention_Pharmacological
CsA
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Intervention_Pharmacological
cyclophosphamide
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Intervention_Pharmacological
CsA-related
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Intervention_Pharmacological
cyclophosphamide
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Outcome_Other
efficacy ( maintenance of remission ) , safety and tolerability
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Outcome_Mortality
Relapse-free survival
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Outcome_Physical
number of N.S
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Outcome_Other
cumulative dose of prednisone/patient
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Outcome_Physical
laboratory investigations ( kidney and liver functions , haematological parameters
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Outcome_Adverse-effects
incidence of adverse events
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Outcome_Physical
complete remission
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Outcome_Physical
partial remission
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Outcome_Other
;
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Outcome_Other
complete remission
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Outcome_Other
partial remission
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Outcome_Physical
risk of relapse
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Outcome_Other
mean number of relapses per year
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Outcome_Other
dose of prednisone per year
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Outcome_Other
relapse of NS . Tolerance
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Outcome_Adverse-effects
CsA-related side-effects
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Outcome_Other
stable remissions .
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Participant_Condition
steroid-dependent and frequently relapsing idiopathic nephrotic syndrome
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Participant_Condition
steroid-dependent or frequently relapsing nephrotic syndrome
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Participant_Condition
NS
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Participant_Age
adults and children
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Participant_Sample-size
Seventy-three
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Participant_Condition
with steroid-sensitive idiopathic NS