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

Coggins 1985.

Methods Country: United States 
 Setting/Design: Collaborative placebo‐controlled RCT 
 Time Frame: NS 
 Randomisation method: NS 
 Blinding 
 ‐ Participants: NS 
 ‐ Investigators: NS 
 ‐ Outcome assessors: NS 
 ‐ Data analyses: NS 
 Intention‐to‐treat: NS 
 Follow‐up period: 77 months 
 Loss to follow‐up: 0%
Participants INCLUSION CRITERIA 
 Idiopathic nephrotic syndrome of minimal change disease
GROUP 1 (prednisone) 
 Number: 14 
 Age: 29 years
GROUP 2 (no treatment) 
 Number: 14 
 Age: 32 years
Interventions GROUP 1 
 Prednisone 125 mg PO given in alternate‐day doses for 2 months. 
 Relapses were re‐treated.
GROUP 2 
 No treatment. 
 If patient reached "stop points" (including doubling of admission creatinine) they were withdrawn from the placebo group and treated with steroids.
COINTERVENTIONS: NS
Outcomes
  1. Complete remission prior to "Stop Point" (doubling of admission creatinine, severe steroid toxicity, and undefined other bad outcomes)

  2. Complete remission

  3. Partial remission

  4. Time to remission (months)

  5. Doubling of serum creatinine

  6. Kidney failure

  7. Steroid‐related toxicity (avascular necrosis)

  8. Mean end of treatment serum creatinine

Notes Exclusions post‐randomisation but pre‐intervention: NS 
 Additional data requested from authors: Method of randomisation, allocation concealment
COMPLETENESS OF FOLLOW‐UP 
 Eligible/considered for inclusion = NS; Enrolled/randomised = 28; Analysed = 28 ; Percent followed = 100
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment? Unclear risk B ‐ Unclear