|
| Visit number | Trial timeline/study visits | Blood tests (renal/liver profiles/cholesterol) | Blood test (PTH) + extra sample | Dietician advice | Pittsburgh Dialysis Symptoms Index | Communicare package | BAASIS | Other events |
|
| 0 | −6 weeks to −3 weeks | | | | | | | Potential participants identified from patient records
Contact made; PIS provided |
|
| 1 | −3 weeks | | | ✓ | | | | Consent
Washout period commences |
|
| 2 | Randomisation
week 0 | ✓ | ✓ | | | ✓ | | Randomisation
Commence oral phosphate binding trial medication— sevelamer or lanthanum |
|
| 3 | 1 week after randomisation | ✓ | | | | | | Titrate trial medication and statins
Discuss symptoms |
|
| 4 | 2 weeks after randomisation | ✓ | | | | | | Titrate trial medication and statins
Discuss symptoms |
|
| 5 | 3 Weeks after randomisation | ✓ | | | | | | Titrate trial medication and statins
Discuss symptoms |
|
| 6 | 4 weeks after randomisation | ✓ | | | | | ✓ | Titrate trial medication and statins
Discuss symptoms |
|
| 7 | 5 weeks after randomisation | ✓ | | | | | | Titrate trial medication and statins
Discuss symptoms |
|
| 8 | 6 weeks after randomisation | ✓ | | | | | | Titrate trial medication and statins
Discuss symptoms |
|
| 9 | 7 weeks after randomisation | ✓ | | | | | | Titrate trial medication and statins
Discuss symptoms |
|
| 10 | 8 weeks after randomisation
| ✓ | ✓ | | | | ✓ | Review medical history
Discuss symptoms
Titrate trial medication and statins if necessary |
|
| 11 | 12 weeks after randomisation | ✓ | | | | ✓ | ✓ | Review medical history
Discuss symptoms
Titrate trial medication and statins if necessary |
|
| 12 | 16 weeks after randomisation | ✓ | | | | | ✓ | Review medical history
Discuss symptoms
Titrate trial medication and statins if necessary |
|
| 13 | 20 weeks after randomisation | ✓ | ✓ | | ✓ | | ✓ | Review medical history
Discuss symptoms Titrate trial medication and statins if necessary |
|
| 14 | 24 weeks after randomisation | ✓ | | | | | ✓ | Review medical history
Discuss symptoms
Titrate trial medication and statins if necessary |
|
| 15 | 28 weeks after randomisation | ✓ | | | | ✓ | ✓ | Review medical history
Discuss symptoms
Titrate trial medication and statins if necessary |
|
| 16 | 32 weeks after randomisation | ✓ | ✓ | | | | ✓ | Review medical history
Discuss symptoms Titrate trial medication and statins if necessary |
|
| 17 | 36 weeks after randomisation | ✓ | | | | | ✓ | Review medical history
Discuss symptoms
Titrate trial medication and statins if necessary |
|
| 18 | 40 weeks after randomisation | ✓ | | | | | ✓ | Review medical history
Discuss symptoms
Titrate trial medication and statins if necessary |
|
| 19 | 44 weeks after randomisation | ✓ | ✓ | | | | ✓ | Review medical history
Discuss symptoms
Titrate trial medication and statins if necessary |
|
| 20 | 48 weeks after randomisation | ✓ | | | | | ✓ | Review medical history
Discuss symptoms
Titrate trial medication and statins if necessary |
|
| 21 | 52 weeks after randomisation | ✓ | | | | | ✓ | Review medical history
Discuss symptoms
Patient’s involvement in the trial ends |
|
