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. 2019 Nov 21;2019(11):CD003594. doi: 10.1002/14651858.CD003594.pub6

Ponticelli 1993a.

Methods

  • Study design: parallel RCT

  • Time frame: not reported

  • Follow‐up period: 1 year
Participants

  • Setting: tertiary, multicentre

  • Country: Italy

  • SRNS proteinuria > 40 mg/m2/h after 5 weeks of prednisone (60 mg/m2/d); age > 2 years; FSGS (9) or MCD (8) on biopsy; all had initial steroid resistance

  • Number (analysed/randomised): CSA group (10/10); no treatment group (7/10)

  • Mean age ± SD (years)

    • CSA group: FSGS group (6.5 ± 4.7); MCD group; 6.8 ± 3.5)

    • No treatment group: FSGS group (6.6 ± 1.8); MCD group (7.5 ± 7.8)

  • Sex (M/F): CSA group (13/9); no treatment group (13/60)

  • Exclusion criteria: secondary nephrotic syndrome; malignancy; concomitant infection; severe hypertension; non‐compliance; abnormal LFTs; other immunosuppressive therapy in previous 12 months
Interventions CSA group

  • 6 mg/kg/d for 6 months adjusted to 250 to 600 ng/mL; taper by 25% every 2 months


No treatment group

  • No treatment. "rescue" treatment with corticosteroids allowed for progressive kidney failure/severe nephrotic syndrome


Co‐interventions

  • Nephrotoxic antibiotics, ACEi, NSAIDs, anti‐epileptic drugs not permitted
Outcomes

  • Complete remission: proteinuria < 4 mg/m2/h on 3 non‐consecutive days during 12 months

  • Partial remission: proteinuria < 40 mg/m2/h on 3 non‐consecutive days during 12 months
Notes

  • Exclusions post randomisation but pre‐intervention: none reported

  • Exclusions post‐intervention: CSA group (0); no treatment group (3 for noncompliance)

  • 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) Low risk Random number table; stratified for adults/children
Allocation concealment (selection bias) Low risk Sealed opaque envelopes numbered in sequence
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 Laboratory measure of primary outcome unlikely to be influenced by lack of blinding.
Incomplete outcome data (attrition bias) 
 All outcomes High risk 3/20 (15%) children (all from no treatment group) lost to follow‐up and not included in results
Selective reporting (reporting bias) High risk No separate data available for adverse events in children
Other bias High risk Funded in part by Sandoz P.F, Milano, Italy