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Table 1 Clinical trial schedule

From: Study protocol: mycophenolate mofetil as maintenance therapy after rituximab treatment for childhood-onset, complicated, frequently-relapsing nephrotic syndrome or steroid-dependent nephrotic syndrome: a multicenter double-blind, randomized, placebo-controlled trial (JSKDC07)

  Screening period Observation period Observation period Follow-up period
(Rituximab administration period) (Investigational drug administration period)
Day Within 35 days 1 8 15 22 29 57 85 113 141 169 225 281 337 393 449 505 Relapse Investigation drug discontinuation 36/48 month Clinical trial discontinuation
Visit   1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16
Obtaining informed consent                    
Medical examination  
Investigation drug administration    
Background survey                    
Concomitant drug survey  
Height/weight
Blood pressure
Pulse, body temperature               
Pregnancy test                    
HIV, HCV, HBVa                    
Electrocardiogram                    
Chest X-ray                    
Relapse evaluation  
Adverse event evaluation  
After treatment                    
Hematological examination  
Immunoglobulin examination                     
Estimated glomerular filtration rate                
Urinalysis
Peripheral blood B cell count      
  1. : Conduct if possible
  2. □: Conduct until the peripheral blood B cell recovery (≥ 5/μL) is confirmed
  3. a HIV human immunodeficiency virus, HCV hepatitis C virus, HBV hepatitis B virus