Sequencing:Article Title: Interventions for idiopathic steroid‐resistant nephrotic syndrome in children
Article Snippet: A secondary outcome defined by the authors of "FSGS partial remission end point (FPRE) (UP/C:≤ 1.5 g/g and > 40% reduction in proteinuria" and not pre‐specified in the protocol was included in meta‐analyses Other bias High risk Trial organised and supported by Retrophin Inc. (San Diego, CA) DUET 2017 Methods Study design: parallel RCT Time frame: 1990 to 1991 Follow‐up period: 12 months Participants Setting: tertiary centre Country: India SRNS, initial (5) and delayed (8) steroid resistance with MCD Number (IV/oral): 7/6 Age range (years): IV group (3 to 16); oral group (9 to 14.5) Sex (M/F): IV group (6/1); oral group (5/1) Exclusion criteria: not reported Interventions IV CPA group IV CPA: 500 mg/m 2 /mo for 6 months Prednisone: 60 mg/m 2 /d for 4 weeks; 40 mg/m 2 alternate days for 4 weeks and taper Oral CPA group Oral CPA: 2.5 mg/kg/d for 8 weeks Prednisone: 60 mg/m 2 /d for 4 weeks; 40 mg/m 2 alternate days for 4 weeks and taper Co‐interventions Not reported Outcomes Remission: proteinuria < 4 mg/m 2 /h and albumin > 35 g/L at 6 months Adverse events Notes Exclusions post randomisation but pre‐intervention: none reported Stop or end points/s: not reported Additional data requested from authors: none Risk of bias Bias Authors' judgement Support for judgement Random sequence generation (selection bias) Unclear risk No information provided Allocation concealment (selection bias) Unclear risk No information provided Blinding of participants and personnel (performance bias) All outcomes High risk No blinding of participants/investigators; lack of blinding could influence management Blinding of outcome assessment (detection bias) All outcomes Low risk Primary outcome was laboratory based and unlikely to be influenced by lack of blinding Incomplete outcome data (attrition bias) All outcomes High risk Loss to follow‐up: 15%; 2 from control group lost to follow‐up and excluded from analysis Selective reporting (reporting bias) Low risk Outcome (complete remission, non‐remission, adverse effects) reported Other bias Unclear risk Funding source not reported Elhence 1994 Methods Study design: parallel RCT (phase 1 study) Time frame: not reported Follow‐up period: 16 weeks Participants Setting: multicentre Country: USA Adults and children aged 2 to 41 years with biopsy‐confirmed primary FSGS and initial steroid resistance; steroid resistance (UP/C > 1.0 g/g after 4 weeks of steroid therapy), persistent proteinuria (UP/C > 1.0 g/g) and eGFR > 40 mL/min/1.73 m 2 ; patients were admitted who failed treatment in the FSGS‐CT Study 2011 or were ineligible for FSGS‐CT Study because of previous use of study interventions; patients off all immunosuppressive agents for at least 4 weeks.
Article Title: Interventions for idiopathic steroid-resistant nephrotic syndrome in children
Article Snippet: A secondary outcome defined by the authors of "FSGS partial remission end point (FPRE) (UP/C:≤ 1.5 g/g and > 40% reduction in proteinuria" and not pre-specified in the protocol was included in meta-analyses Other bias High risk Trial organised and supported by Retrophin Inc. (San Diego, CA) DUET 2017 (Continued) Methods • Study design: parallel RCTElhence 1994 Interventions for idiopathic steroid-resistant nephrotic syndrome in children (Review) Copyright © 2019 The Cochrane Collaboration.
Selection:Article Title: Interventions for idiopathic steroid‐resistant nephrotic syndrome in children
Article Snippet: A secondary outcome defined by the authors of "FSGS partial remission end point (FPRE) (UP/C:≤ 1.5 g/g and > 40% reduction in proteinuria" and not pre‐specified in the protocol was included in meta‐analyses Other bias High risk Trial organised and supported by Retrophin Inc. (San Diego, CA) DUET 2017 Methods Study design: parallel RCT Time frame: 1990 to 1991 Follow‐up period: 12 months Participants Setting: tertiary centre Country: India SRNS, initial (5) and delayed (8) steroid resistance with MCD Number (IV/oral): 7/6 Age range (years): IV group (3 to 16); oral group (9 to 14.5) Sex (M/F): IV group (6/1); oral group (5/1) Exclusion criteria: not reported Interventions IV CPA group IV CPA: 500 mg/m 2 /mo for 6 months Prednisone: 60 mg/m 2 /d for 4 weeks; 40 mg/m 2 alternate days for 4 weeks and taper Oral CPA group Oral CPA: 2.5 mg/kg/d for 8 weeks Prednisone: 60 mg/m 2 /d for 4 weeks; 40 mg/m 2 alternate days for 4 weeks and taper Co‐interventions Not reported Outcomes Remission: proteinuria < 4 mg/m 2 /h and albumin > 35 g/L at 6 months Adverse events Notes Exclusions post randomisation but pre‐intervention: none reported Stop or end points/s: not reported Additional data requested from authors: none Risk of bias Bias Authors' judgement Support for judgement Random sequence generation (selection bias) Unclear risk No information provided Allocation concealment (selection bias) Unclear risk No information provided Blinding of participants and personnel (performance bias) All outcomes High risk No blinding of participants/investigators; lack of blinding could influence management Blinding of outcome assessment (detection bias) All outcomes Low risk Primary outcome was laboratory based and unlikely to be influenced by lack of blinding Incomplete outcome data (attrition bias) All outcomes High risk Loss to follow‐up: 15%; 2 from control group lost to follow‐up and excluded from analysis Selective reporting (reporting bias) Low risk Outcome (complete remission, non‐remission, adverse effects) reported Other bias Unclear risk Funding source not reported Elhence 1994 Methods Study design: parallel RCT (phase 1 study) Time frame: not reported Follow‐up period: 16 weeks Participants Setting: multicentre Country: USA Adults and children aged 2 to 41 years with biopsy‐confirmed primary FSGS and initial steroid resistance; steroid resistance (UP/C > 1.0 g/g after 4 weeks of steroid therapy), persistent proteinuria (UP/C > 1.0 g/g) and eGFR > 40 mL/min/1.73 m 2 ; patients were admitted who failed treatment in the FSGS‐CT Study 2011 or were ineligible for FSGS‐CT Study because of previous use of study interventions; patients off all immunosuppressive agents for at least 4 weeks.
Article Title: Interventions for idiopathic steroid-resistant nephrotic syndrome in children
Article Snippet: A secondary outcome defined by the authors of "FSGS partial remission end point (FPRE) (UP/C:≤ 1.5 g/g and > 40% reduction in proteinuria" and not pre-specified in the protocol was included in meta-analyses Other bias High risk Trial organised and supported by Retrophin Inc. (San Diego, CA) DUET 2017 (Continued) Methods • Study design: parallel RCTElhence 1994 Interventions for idiopathic steroid-resistant nephrotic syndrome in children (Review) Copyright © 2019 The Cochrane Collaboration.
Control:Article Title: Interventions for idiopathic steroid‐resistant nephrotic syndrome in children
Article Snippet: A secondary outcome defined by the authors of "FSGS partial remission end point (FPRE) (UP/C:≤ 1.5 g/g and > 40% reduction in proteinuria" and not pre‐specified in the protocol was included in meta‐analyses Other bias High risk Trial organised and supported by Retrophin Inc. (San Diego, CA) DUET 2017 Methods Study design: parallel RCT Time frame: 1990 to 1991 Follow‐up period: 12 months Participants Setting: tertiary centre Country: India SRNS, initial (5) and delayed (8) steroid resistance with MCD Number (IV/oral): 7/6 Age range (years): IV group (3 to 16); oral group (9 to 14.5) Sex (M/F): IV group (6/1); oral group (5/1) Exclusion criteria: not reported Interventions IV CPA group IV CPA: 500 mg/m 2 /mo for 6 months Prednisone: 60 mg/m 2 /d for 4 weeks; 40 mg/m 2 alternate days for 4 weeks and taper Oral CPA group Oral CPA: 2.5 mg/kg/d for 8 weeks Prednisone: 60 mg/m 2 /d for 4 weeks; 40 mg/m 2 alternate days for 4 weeks and taper Co‐interventions Not reported Outcomes Remission: proteinuria < 4 mg/m 2 /h and albumin > 35 g/L at 6 months Adverse events Notes Exclusions post randomisation but pre‐intervention: none reported Stop or end points/s: not reported Additional data requested from authors: none Risk of bias Bias Authors' judgement Support for judgement Random sequence generation (selection bias) Unclear risk No information provided Allocation concealment (selection bias) Unclear risk No information provided Blinding of participants and personnel (performance bias) All outcomes High risk No blinding of participants/investigators; lack of blinding could influence management Blinding of outcome assessment (detection bias) All outcomes Low risk Primary outcome was laboratory based and unlikely to be influenced by lack of blinding Incomplete outcome data (attrition bias) All outcomes High risk Loss to follow‐up: 15%; 2 from control group lost to follow‐up and excluded from analysis Selective reporting (reporting bias) Low risk Outcome (complete remission, non‐remission, adverse effects) reported Other bias Unclear risk Funding source not reported Elhence 1994 Methods Study design: parallel RCT (phase 1 study) Time frame: not reported Follow‐up period: 16 weeks Participants Setting: multicentre Country: USA Adults and children aged 2 to 41 years with biopsy‐confirmed primary FSGS and initial steroid resistance; steroid resistance (UP/C > 1.0 g/g after 4 weeks of steroid therapy), persistent proteinuria (UP/C > 1.0 g/g) and eGFR > 40 mL/min/1.73 m 2 ; patients were admitted who failed treatment in the FSGS‐CT Study 2011 or were ineligible for FSGS‐CT Study because of previous use of study interventions; patients off all immunosuppressive agents for at least 4 weeks.
Article Title: Interventions for idiopathic steroid-resistant nephrotic syndrome in children
Article Snippet: A secondary outcome defined by the authors of "FSGS partial remission end point (FPRE) (UP/C:≤ 1.5 g/g and > 40% reduction in proteinuria" and not pre-specified in the protocol was included in meta-analyses Other bias High risk Trial organised and supported by Retrophin Inc. (San Diego, CA) DUET 2017 (Continued) Methods • Study design: parallel RCTElhence 1994 Interventions for idiopathic steroid-resistant nephrotic syndrome in children (Review) Copyright © 2019 The Cochrane Collaboration.
Comparison:Article Title: Interventions for idiopathic steroid‐resistant nephrotic syndrome in children
Article Snippet: A secondary outcome defined by the authors of "FSGS partial remission end point (FPRE) (UP/C:≤ 1.5 g/g and > 40% reduction in proteinuria" and not pre‐specified in the protocol was included in meta‐analyses Other bias High risk Trial organised and supported by Retrophin Inc. (San Diego, CA) DUET 2017 Methods Study design: parallel RCT Time frame: 1990 to 1991 Follow‐up period: 12 months Participants Setting: tertiary centre Country: India SRNS, initial (5) and delayed (8) steroid resistance with MCD Number (IV/oral): 7/6 Age range (years): IV group (3 to 16); oral group (9 to 14.5) Sex (M/F): IV group (6/1); oral group (5/1) Exclusion criteria: not reported Interventions IV CPA group IV CPA: 500 mg/m 2 /mo for 6 months Prednisone: 60 mg/m 2 /d for 4 weeks; 40 mg/m 2 alternate days for 4 weeks and taper Oral CPA group Oral CPA: 2.5 mg/kg/d for 8 weeks Prednisone: 60 mg/m 2 /d for 4 weeks; 40 mg/m 2 alternate days for 4 weeks and taper Co‐interventions Not reported Outcomes Remission: proteinuria < 4 mg/m 2 /h and albumin > 35 g/L at 6 months Adverse events Notes Exclusions post randomisation but pre‐intervention: none reported Stop or end points/s: not reported Additional data requested from authors: none Risk of bias Bias Authors' judgement Support for judgement Random sequence generation (selection bias) Unclear risk No information provided Allocation concealment (selection bias) Unclear risk No information provided Blinding of participants and personnel (performance bias) All outcomes High risk No blinding of participants/investigators; lack of blinding could influence management Blinding of outcome assessment (detection bias) All outcomes Low risk Primary outcome was laboratory based and unlikely to be influenced by lack of blinding Incomplete outcome data (attrition bias) All outcomes High risk Loss to follow‐up: 15%; 2 from control group lost to follow‐up and excluded from analysis Selective reporting (reporting bias) Low risk Outcome (complete remission, non‐remission, adverse effects) reported Other bias Unclear risk Funding source not reported Elhence 1994 Methods Study design: parallel RCT (phase 1 study) Time frame: not reported Follow‐up period: 16 weeks Participants Setting: multicentre Country: USA Adults and children aged 2 to 41 years with biopsy‐confirmed primary FSGS and initial steroid resistance; steroid resistance (UP/C > 1.0 g/g after 4 weeks of steroid therapy), persistent proteinuria (UP/C > 1.0 g/g) and eGFR > 40 mL/min/1.73 m 2 ; patients were admitted who failed treatment in the FSGS‐CT Study 2011 or were ineligible for FSGS‐CT Study because of previous use of study interventions; patients off all immunosuppressive agents for at least 4 weeks.
Article Title: Interventions for idiopathic steroid-resistant nephrotic syndrome in children
Article Snippet: A secondary outcome defined by the authors of "FSGS partial remission end point (FPRE) (UP/C:≤ 1.5 g/g and > 40% reduction in proteinuria" and not pre-specified in the protocol was included in meta-analyses Other bias High risk Trial organised and supported by Retrophin Inc. (San Diego, CA) DUET 2017 (Continued) Methods • Study design: parallel RCTElhence 1994 Interventions for idiopathic steroid-resistant nephrotic syndrome in children (Review) Copyright © 2019 The Cochrane Collaboration.
Infection:Article Title: Interventions for idiopathic steroid‐resistant nephrotic syndrome in children
Article Snippet: A secondary outcome defined by the authors of "FSGS partial remission end point (FPRE) (UP/C:≤ 1.5 g/g and > 40% reduction in proteinuria" and not pre‐specified in the protocol was included in meta‐analyses Other bias High risk Trial organised and supported by Retrophin Inc. (San Diego, CA) DUET 2017 Methods Study design: parallel RCT Time frame: 1990 to 1991 Follow‐up period: 12 months Participants Setting: tertiary centre Country: India SRNS, initial (5) and delayed (8) steroid resistance with MCD Number (IV/oral): 7/6 Age range (years): IV group (3 to 16); oral group (9 to 14.5) Sex (M/F): IV group (6/1); oral group (5/1) Exclusion criteria: not reported Interventions IV CPA group IV CPA: 500 mg/m 2 /mo for 6 months Prednisone: 60 mg/m 2 /d for 4 weeks; 40 mg/m 2 alternate days for 4 weeks and taper Oral CPA group Oral CPA: 2.5 mg/kg/d for 8 weeks Prednisone: 60 mg/m 2 /d for 4 weeks; 40 mg/m 2 alternate days for 4 weeks and taper Co‐interventions Not reported Outcomes Remission: proteinuria < 4 mg/m 2 /h and albumin > 35 g/L at 6 months Adverse events Notes Exclusions post randomisation but pre‐intervention: none reported Stop or end points/s: not reported Additional data requested from authors: none Risk of bias Bias Authors' judgement Support for judgement Random sequence generation (selection bias) Unclear risk No information provided Allocation concealment (selection bias) Unclear risk No information provided Blinding of participants and personnel (performance bias) All outcomes High risk No blinding of participants/investigators; lack of blinding could influence management Blinding of outcome assessment (detection bias) All outcomes Low risk Primary outcome was laboratory based and unlikely to be influenced by lack of blinding Incomplete outcome data (attrition bias) All outcomes High risk Loss to follow‐up: 15%; 2 from control group lost to follow‐up and excluded from analysis Selective reporting (reporting bias) Low risk Outcome (complete remission, non‐remission, adverse effects) reported Other bias Unclear risk Funding source not reported Elhence 1994 Methods Study design: parallel RCT (phase 1 study) Time frame: not reported Follow‐up period: 16 weeks Participants Setting: multicentre Country: USA Adults and children aged 2 to 41 years with biopsy‐confirmed primary FSGS and initial steroid resistance; steroid resistance (UP/C > 1.0 g/g after 4 weeks of steroid therapy), persistent proteinuria (UP/C > 1.0 g/g) and eGFR > 40 mL/min/1.73 m 2 ; patients were admitted who failed treatment in the FSGS‐CT Study 2011 or were ineligible for FSGS‐CT Study because of previous use of study interventions; patients off all immunosuppressive agents for at least 4 weeks.
Article Title: Interventions for idiopathic steroid-resistant nephrotic syndrome in children
Article Snippet: A secondary outcome defined by the authors of "FSGS partial remission end point (FPRE) (UP/C:≤ 1.5 g/g and > 40% reduction in proteinuria" and not pre-specified in the protocol was included in meta-analyses Other bias High risk Trial organised and supported by Retrophin Inc. (San Diego, CA) DUET 2017 (Continued) Methods • Study design: parallel RCTElhence 1994 Interventions for idiopathic steroid-resistant nephrotic syndrome in children (Review) Copyright © 2019 The Cochrane Collaboration.
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