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Table 2 Trial-specific and routine procedures performed during the interventional trial

From: A multicentre, patient- and assessor-blinded, non-inferiority, randomised and controlled phase II trial to compare standard and torque teno virus-guided immunosuppression in kidney transplant recipients in the first year after transplantation: TTVguideIT

Post-TX month

 

1

2

3

4

5

 

8

 

11

12 to 13

Study week

 

−12 to −11

−8

−4

0

6

12

18

24

30

36

Study visit

 

−3

−2

−1

1

2

3

4

5

6

7 (FUP)

Informed consent

 

X

         

Inclusion/ exclusion criteria

 

X

  

X

      

Intervention

    

X

X

X

X

X

X

 

Medical history

 

X

  

X

      

Vital signs

    

X

X

X

X

X

X

X

Physical examination, body weight

    

X

     

X

Pregnancy test

    

X

     

X

Medication

    

X

X

X

X

X

X

X

Adverse eventsa

     

X

X

X

X

X

X

Primary endpointa

     

X

X

X

X

X

X

Laboratory workup

TTV R-GENE®

X

X

X

X

X

X

X

X

X

X

 

TAC trough level

 

X

X

X

X

X

X

X

X

X

 

Chemistry, CBC, vBGA, urine analysisb

 

X

X

X

X

X

X

X

X

X

 

BKV, CMVb

   

X

X

X

X

X

X

X

 

DSA

   

X

     

X

Biobankingc

Whole blood, serum, plasma, urine

X

X

X

X

X

X

X

X

X

X

Drug adherenced

MEMS® BUTTON

   

X

X

X

X

X

X

X

 

BAASIS

   

X

X

X

X

X

X

X

 

Patient diary

   

X

X

X

X

X

X

X

 

Claimed prescription check

         

X

 

Psychological evaluation

   

X

     

X

Quality of life

SF-36, MTSOSD-59R

   

X

     

X

Protocol biopsye

    

X

     

X

  1. BKV BK virus, CBC Complete blood count, CMV Cytomegalovirus, DSA Donor-specific antibodies, HLA Human leucocyte antigen, FUP Follow-up, MTSOSD-59R Modified Transplant Symptom Occurrence and Symptom Distress Scale 59R, rt-PCR Real-time polymerase chain reaction, SF-36 Medical Outcomes Study Short Form 36, TAC Tacrolimus, TTV Torque teno virus, TX Transplantation, vBGA Venous blood gas analysis
  2. a Check-ups concerning infections and other adverse events will be performed additionally via telephone calls every 2 weeks
  3. b Laboratory workup and virology screening will be performed not as part of the study protocol but according to local centre standards. However, according to the study protocol, at least the leucocyte count, creatinine, and urinary protein- and albumin-to-creatinine ratio will have to be assessed. Other major laboratory parameters and findings concerning CMV and BKV screening, including plasma CMV and BKV PCR performed routinely at the centres, will be noted
  4. c Biological material will be stored for additional immunological monitoring according to a sub-study
  5. d Adherence will be monitored during the trial by a patient diary and evaluated at every visit; other assessments of adherence will be evaluated retrospectively
  6. e Protocol biopsies (including molecular microscopy) will not be performed as part of the study protocol but according to local centre standards. However, the results of protocol biopsies obtained as part of the routine local centre standard will be noted. If part of the centre standard, the month 3 protocol biopsy has to be performed before V1
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ISSN: 1745-6215