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. 2008 Jan 23;2008(1):CD001537. doi: 10.1002/14651858.CD001537.pub4

Imbasciati 1985.

Methods Country: Italy 
 Setting/Design: Multicentre RCT 
 Time Frame: June 1980 to June 1983 
 Randomisation method: Table of random numbers kept in one centre 
 Blinding 
 ‐ Participants: No 
 ‐ Investigators: No 
 ‐ Outcome assessors: NS 
 ‐ Data analyses: NS 
 Intention‐to‐treat: Yes 
 Follow‐up period: 12‐24 months 
 Loss to follow‐up: 0%
Participants INCLUSION CRITERIA
  1. Proteinuria > 3.5 g/24 h persisting for at least 2 weeks and plasma albumin concentration < 25 g/L.

  2. No secondary cause for nephrotic syndrome.

  3. Not been treated with steroids or cytotoxic agents for at least one year before admission.

  4. Kidney biopsy shows clear histological picture consistent with MCD.


GROUP 1 (Methylprednisone + prednisone) 
 Number: 11 
 Age: NS
GROUP 2 (Prednisone alone) 
 Number: 11 
 Age: NS
Interventions GROUP 1 
 Methylprednisone 20 mg/kg/d IV for 3 days; then prednisone 0.5 mg/kg/d for 4 weeks PO; then 0.25‐0.5 mg/kg/alternate days PO for 4 weeks; then 0.5 mg/kg/alternate days PO for 4 months.
GROUP 2 
 Prednisone 1 mg/kg/d for 4 weeks; then 1 mg/kg/alternate days for 4 weeks; then 0.5 mg/kg on alternate days 4 months.
COINTERVENTIONS 
 Low salt diet, diuretics, anti‐hypertensive changes as needed.
Outcomes
  1. Complete remission within 8 weeks of treatment

  2. Time to remission (days)

  3. Relapse of nephrotic syndrome during follow‐up

  4. Number of relapses/patient/year follow‐up

  5. Proportion of patients remaining in remission

  6. Treatment‐related toxicity

  7. Nephrotic syndrome‐related adverse events

Notes Exclusions post‐randomisation but pre‐intervention: 0 
 Additional data requested from authors: Allocation concealment, age of participants, mean time to remission
COMPLETENESS OF FOLLOW‐UP 
 Eligible/considered for inclusion = NS; Enrolled/randomised = 89; Analysed = 89; Percent followed = 100
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment? Unclear risk B ‐ Unclear