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 | ||||||
Biobanking – 10 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 |