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Table 2 Schedule of enrolment, interventions, and assessments

From: The Calcineurin Inhibitor-Sparing (CIS) Trial - individualised calcineurin-inhibitor treatment by immunomonitoring in renal allograft recipients: protocol for a randomised controlled trial

  STUDY PERIOD
PHASE Baseline Post-allocation End of study
Visit 1 2 3 4
Day 0    
Month   1 ± 7d 3 ± 14d 6 ± 14d
ENROLMENT     
Eligibility screen x    
Inclusion/exclusion x    
Randomisation (allocation) x    
INTERVENTIONS     
Intervention A (control group): adaption of CsA according to CsA C0 x x x  
Intervention B (investigational group): adaption of CsA according to NFAT-expression x x x  
ASSESSMENTS     
Demography x    
General medical history x    
Transplantation information x    
Physical examination x    x
Vital signs x x x x
Study medication check   x x x
Laboratory test:     
 Hematocrit/Biochemistry     
  basic program   x x  
  extended program x    x
 Urinanalysis x    x
 CsA C0 and C2 levels x x x x
 NFAT-regulated gene expression x x x x
Pulse wave velocity x   x x
Rejection episodes as necessary
Renal biopsy as necessary
Adverse events as necessary
Severe adverse events as necessary
Comments as necessary
Concomitant therapy as necessary
Immunosuppressive therapy x x x x
Framingham score x    x
Quality of life assessment x    x
  1. C0, CsA trough level; C2, two-hour level; CsA, ciclosporin A; NFAT, nuclear factor of activated T-cell.