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Table 3 Timing of study procedures

From: Rationale and design of the OPTIMIZE trial: OPen label multicenter randomized trial comparing standard IMmunosuppression with tacrolimus and mycophenolate mofetil with a low exposure tacrolimus regimen In combination with everolimus in de novo renal transplantation in Elderly patients

 

BASELINE

Day 7

Week 4

Mo 3

Mo 6

Mo 9

Mo 12

Mo 18

Mo 24

Day

0

7

28

90

180

270

360

540

720

Time window (+/- days)

 

+/-2

+/-7

+/-14

+/-21

+/-21

+/-21

+/-21

+/-21

Demographics

X

        

Medical history

X

        

Donor & transplantation related information

X

        

Dialysis information

X

X

X

X

     

Vital signs - Height (only at baseline), blood pressure, weight, heart rate

X

X

X

X

X

X

X

X

X

Trough levels CNI/EVR

 

X

X

X

X

X

X

X

X

Haematology - Hb, Ht, MCV, leucocytes + differentiation, platelets

X

 

X

X

X

X

X

X

X

Biochemistry - Creatinine, sodium, potassium, albumin, calcium, phosphate, glucose, HbA1c

X

 

X

X

X

X

X

X

X

Lipid Profile - Cholesterol (total, HDL and LDL) and triglycerides

X

  

X

X

X

X

X

X

24 hour Urine - Protein, sodium, creatinine clearance

    

X

 

X

 

X

Spot urine - Creatinine, protein

X

 

X

X

X

X

X

X

X

Virology Cytomegalovirus PCR, BK-virus PCR

   

X

X

 

X

  

Biobanking10 ml EDTA, 10 ml serum, 8 ml urine (urine not at baseline)

X

   

X

 

X

 

X

Optional: PBMCs – 3 x 10 ml lithium heparin (+ lymphocyte subset)

X

     

X

 

X

DSA

X

     

X

 

X

Tests and questionnaires 1 - Grip strength, CFS, SF-12, EQ-5D, B-IPQ, DSI + MTSOSD-59

X

     

X

 

X

Tests and questionnaires 2 – FFI, SPPB, MoCA, BAASIS

      

X

 

X

Secondary endpoint status

 

X

X

X

X

X

X

X

X

Study medication status

 

X

X

X

X

X

X

X

X

Concomitant medication

X

X

X

X

X

X

X

X

X

Adverse events

X

X

X

X

X

X

X

X

X

  1. PBMCs Peripheral Blood Mononuclear Cells, DSA donor-specific anti-HLA antibodies, CFS Clinical Frailty Scale, SF-12 Short Form -12 (SF-12), EQ-5D European Quality of life-5 Dimensions, B-IPQ Brief Illness Perception Questionnaire, DSI Dialysis Symptom Index, MTSOSD-59 Modified Transplant Symptom Occurrence and Symptom Distress Scale-59, FFI Fried Frailty Index, MoCA Montreal Cognitive Assessment, SPPB short physical performance battery, BAASIS Basel Assessment of Adherence to Immunosuppressive Medication Scale