Visit | Baseline KT | Month 1 | Month 2 Pre-randomization Screening | Month 3 Randomization | Month 4 | Month 6 | Month 9 | Month 12 | Month 18 | Month 24 |
---|---|---|---|---|---|---|---|---|---|---|
1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | |
Informed consent | X | |||||||||
Clinical and demographic data | X | X | X | X | X | X | X | X | X | X |
Pregnancy test | X | X | ||||||||
Randomization criteria | X | X | ||||||||
Clinical incidents (hypertension, diabetes, dyslipidemia) | X | X | X | X | X | X | X | X | X | X |
Kidney graft biopsy | X | X | ||||||||
General lab testsa | X | X | X | X | X | X | X | X | X | X |
Anti-HLA (DSA) antibodies | X | X | X | |||||||
Renal function (CKD-EPI) | X | X | X | X | X | X | X | X | X | |
Proteinuria | X | X | X | X | X | X | X | X | X | |
Urinary chemokines (CXCL9 and CXCL10) | X | X | X | X | X | |||||
Elisa Kits: Klotho, FGF-23 TNF and TWEAK/Fn14 | X | X | X | X | X | |||||
Assessment of therapeutic compliance (BAASIC scale) | X | X | X |