Schedule of visits for the IMPROVE-CKD study
| Baseline | Weeks postbaseline (Study visit window is ±14 days of due date from baseline) | |||||||||
| Week 12 | Week 24 | Week 36 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 | |||
| Visits | Screening/ randomisation | Visit 1, month 3 | Visit 2, month 6 | Visit 3, month 9 | Visit 4, month 12 | Visit 5, month 15 | Visit 6, month 18 | Visit 7, month 21 | END month 24 | |
| Visit assessments | ||||||||||
| Informed consent | X | |||||||||
| Participant randomised | X | |||||||||
| ECG | X | |||||||||
| Demographics and medical history | X | |||||||||
| Physical examination | X | X | X | X | X | |||||
| Concomitant medications | X | X | X | X | X | X | X | X | X | |
| CT scan: multislice, non-contrast * | X | X | ||||||||
| Pulse wave velocity and augmentation index | X | X | X | X | X | |||||
| Cardiac MRI * (for participating sites) | X | X | ||||||||
| Medication dispensed | X | X | X | X | X | X | X | X | ||
| Medication returned | X | X | X | X | X | X | X | X | ||
| Adverse events recorded (SAEs and ADRs) | X | X | X | X | X | X | X | X | ||
| Dietitian assisted food record† (for participating sites) | X | X | X | |||||||
*If participants withdraw from the study after 12 months and prior to 24 months, they will be requested to do a ‘close-out’ CT and MRI scan. Some sites will also perform additional MRI scans to investigate diastolic dysfunction.
†For participants enrolled in the dietary component of the study.
ADRs, adverse drug reactions; IMPROVE-CKD, Impact of Phosphate Reduction On Vascular End-points in CKD; SAEs, serious adverse events.