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Table 2 Flow chart of study visits

From: A multicenter, randomized, open-labeled study to steer immunosuppressive and antiviral therapy by measurement of virus (CMV, ADV, HSV)-specific T cells in addition to determination of trough levels of immunosuppressants in pediatric kidney allograft recipients (IVIST01-trial): study protocol for a randomized controlled trial

Week/month (after transplantation) Months 1-3 (±3 days) Months 4-12 (±7 days) Months 13-24 (–7 days)
Week Monthly (except months 6 and 12) Months Bimonthly (except month 24) Month
0 4* 6 8 10 12   6 12   24
Visits   1 2 3 4 4 6-14 8 14 15-20 20
Informed consent1   X          
Randomization   X          
Inclusion/exclusion criteria   X          
Medical history   X          
Transplantation X           
Pregnancy test as appropriate2   X          
Vital signs (weight, blood pressure, pulse)   X X X X X X X X X X
Height   X   X   X X X X X X
Hematology (including differential count)   X X X X X X X X X X
Chemistry panel (bilirubine., SGOT, SGPT, yGT, GlDH, CK, LDH)3   X      (X)   X (X) X
Lipid profile (cholesterol, LDL, HDL, triglycerides)   X       X X   X
Serum creatinine, urea   X X X X X X X X X X
Urine analysis (sticks, quantitative urine albumin and creatinine)   X X X X X X X X X X
Trough level of CsA4   X X X X X X X X X X
Trough level of everolimus4   X X X X X X X X X X
CMV-, ADV-, HSV-specific T cells5   X X X X X X X X X X
CMV, HSV, EBV IgG, IgM   X X X X X X X X X X
CMV, ADV, EBV HSV-PCR   X X X X X X X X X X
Clinical assessment   X   X X X X X X X X
Protocol biopsy   X X X X X X X    
CsA half dose and start everolimus   X X X X X X X    
Start of steroid elimination   X X X X X X X    
Treatment of rejection6   X X X X X X X (X) (X) (X)
Prior/concomitant medications   X X X X X X X X X X
Adverse events X X X X X X X X X X X
  1. *Study start. 1Confirmation of informed consent prior to study start. 2Results must be available before study start. 3Chemistry panel is performed every 4 months. 4Levels at indicated time points will be documented on case report form (CRF) summary pages. 5Results at indicated time points will be documented on CRF summary page, analysis will be performed at Hannover Medical School; determination only in the intervention group. 6For all rejection episodes, a core renal biopsy should be performed; results of the biopsy and treatment of rejection will be documented in the medical record and recorded on the CRF. ADV, adenovirus; CK, creatine kinase; CMV, cytomegalovirus; CsA, cyclosporine A; EBV, Epstein-Barr virus; GIDH Glutamate dehydrogenase; HDL, high-density lipoprotein; HSV, herpes-simplex-virus; Ig, immunoglobulin; LDH; LDL, low-density lipoprotein; PCR, polymerase chain reaction; SGOT, serum glutamic oxaloacetic transaminase; SGPT, serum glutamic pyruvic transaminase; yGT, gamma-glutamyl-transferase.