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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

â—‹

                   

Medical examination

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

 

Investigation drug administration

 

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

 

Background survey

â—‹

                   

Concomitant drug survey

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

 

Height/weight

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â–³

â—‹

Blood pressure

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â–³

â—‹

Pulse, body temperature

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

    

â—‹

  

â—‹

  

â—‹

 

â–³

 

Pregnancy test

â—‹

                   

HIV, HCV, HBVa

â—‹

                   

Electrocardiogram

â—‹

               

â—‹

 

â–³

 

Chest X-ray

â—‹

               

â—‹

 

â–³

 

Relapse evaluation

 

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

Adverse event evaluation

 

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

After treatment

                   

â—‹

Hematological examination

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â–³

 

Immunoglobulin examination

 

â—‹

    

â—‹

 

â—‹

 

â—‹

  

â—‹

  

â—‹

 

â–³

 

Estimated glomerular filtration rate

â—‹

â—‹

  

â—‹

â—‹

    

â—‹

  

â—‹

  

â—‹

â—‹

â—‹

 

Urinalysis

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

Peripheral blood B cell count

â—‹

â—‹

â—‹

 

â—‹

â—‹

â—‹

 

â—‹

 

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â–¡

  1. â–³: 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