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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.
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Trials

ISSN: 1745-6215