Sinha 2015

Methods	Study design: parallel RCT Time frame: enrolment commenced April 2012 Follow‐up period: 12 months from randomisation of responders to 6 months of treatment with TAC
Participants	Setting: tertiary, multicentre study Country: India SRNS 60 of 84 patients who entered study and achieved complete remission with 6 months treatment with TAC; included initial (28) or late (32) non‐responders; FSGS (26), MCD (34) on biopsy. CrCl > 60 mL/min/1.73m2; SRNS defined as no response to treatment with oral prednisolone at 2 mg/kg/d for 4 weeks, in absence of significant infection with UP/C > 2 mg/mg; biopsy showing MCD or FSGS; aged 1 to 18 years at onset of disease Number TAC group: 31 MMF group: 29 Age (mean ± SD) TAC group: 76 ± 46 months MMF group: 77 ± 46 months Sex (M/F) TAC group: no information provided MMF group: no information provided Exclusion criteria: failure to achieve remission with TAC; patients with initial steroid resistance who have received treatment with non‐corticosteroid immunosuppressive medications; patients with late steroid resistance who have ever received MMF or tacrolimus exceeding 14 days; or other immunosuppressive medications in the preceding 3 months; infection with hepatitis B,C, parvovirus, HIV, TB; nephrotic syndrome secondary to infections, IgA nephropathy, systemic disease; GFR < 60 mL/min/1.73 m2; allergy to study medications; history of malignancy, DM, organ or bone marrow transplant
Interventions	TAC group 0.15 mg/kg/d aiming for trough levels of 4 to 8 ng/ml MMF group 0.75 to 1 g/m2/d TAC tapered and discontinued within two weeks of randomisation Co‐interventions Prednisolone on alternate days (dose tapered) Enalapril
Outcomes	Number with complete or partial remission Number with infrequent relapses Number with frequent relapses Number with recurrence of steroid resistance Relapse per year Change in GFR
Notes	Abstract only Enrolment was closed after interim ITT analysis of outcome in 1/3 sample
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Stratified block randomisation; stratified for histology and type of response
Allocation concealment (selection bias)	Low risk	Sequentially numbered, sealed, opaque envelopes
Blinding of participants and personnel (performance bias) All outcomes	High risk	No blinding and lack of blinding could result in differences in management
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	No information provided on how outcome was measured
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Abstract only; complete follow‐up to 12 months
Selective reporting (reporting bias)	Unclear risk	Abstract only
Other bias	Unclear risk	No information provided