Sinha 2017.

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) Mean age, range (months): TAC group 66.6, 44.5 to 115.8); MMF group (67.5, 53 to 112.4) Sex (M/F): TAC group (23/8); MMF group (21/8) 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, collapsing glomerulopathy, 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 7 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 (primary outcome) Treatment failure: (i) recurrence of late resistance, (ii) occurrence of frequent relapses and (iii) elevated serum creatinine > 30% and/or eGFR < 50 mL/min/1.73 m2 persisting for > 2 weeks Relapse per year Change in GFR Adverse events
Notes	Enrolment was closed after interim ITT analysis of outcome in 1/3 sample CTRI/2012/03/002479
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Permutated block randomisation; stratified for histology (FSGS or MCD) and type of remission (complete or partial)
Allocation concealment (selection bias)	Low risk	Allocation sequence, in a 1:1 ratio, was generated using Stata version 10.1 (StataCorp version 10, StataCorp College Station, TX) and sealed in opaque envelopes that were opened at randomisation by an investigator blinded to the randomisation schedule
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	Low risk	Complete or partial remission was laboratory based, using UPCR (primary outcome); relapses were defined by dipstick
Incomplete outcome data (attrition bias) All outcomes	Low risk	Follow‐up to 12 months of all but 1 patient (last analysis carried forwards) so data on all patients included in analyses
Selective reporting (reporting bias)	Low risk	Expected outcomes reported
Other bias	Low risk	Study medications were provided by Panacea Biotec (India), which had no role in study development, implementation, or analysis. The study was in part supported by personnel from the Pediatric Renal Biology Program, funded by the Department of Biotechnology, Government of India.