Table 3.
Rescue algorithm for anaemia management
| Evaluate subject for rescue if: HemoCue Hb remains <9 g/dL (at a scheduled study visit, Week 4 onwards) despite threea consecutive dose increases above the starting or post-rescueb dose (where HemoCue Hb is <9 g/dL before each dose increase) or HemoCue Hb is <7.5 g/dL despite a dose increase at the prior study visit. | |
|
Step 1: Initial intervention |
While continuing randomized treatment (increase dose if HemoCue Hb <7.5 g/dL; otherwise maintain current dose), intervene with one or more of the following as dictated by clinical comorbidities • Single course of IV iron up to 1000 mg (in addition to the iron management criteria) • Transfusion of up to two units of PRBC if clinically indicated • Allow additional 4 weeks on randomised treatment (Note: this is a required choice; can be combined with either or both of the above) |
| Step 2: Rescue |
Check HemoCue Hb 4 weeks ± 1 week from last study visit; earlier checks of Hb may be obtained to advise further intervention as clinically indicated Randomized treatment should be permanently discontinued and the subject should be rescued according to local clinical practice if either • HemoCue Hb remains <9 g/dL despite initial intervention based on the average of two HemoCue Hb valuesc or • More than two units of PRBC were needed for transfusion (and was not related to acute bleeding) |
Hb, haemoglobin; PRBC, packed red blood cells.
Two consecutive dose increases if starting/post-rescue dose is daprodustat 12 mg or darbepoetin alfa 200 µg over 4 weeks, one dose increase if starting/post-rescue dose is daprodustat 16 mg or darbepoetin alfa 300 µg over 4 weeks; and no prior dose increase if starting/post-rescue dose is daprodustat 24 mg or darbepoetin alfa 400 µg over 4 weeks (top dose).
For subjects who previously were evaluated for rescue and who are able to continue in the trial, ‘post-rescue’ dose is the dose of randomized treatment that a subject is receiving at the study visit after initial intervention.
Repeat HemoCue Hb at the same study visit to confirm Hb (using the same sample); take average of two values.