The LIFT trial: study protocol for a double-blind, randomised, placebo-controlled trial of K+-binder Lokelma for maximisation of RAAS inhibition in CKD patients with heart failure

Table 1 Study activity schedule and procedures

	Screening	C1	C2	C3	C4	C5	C6	C7 or final visit
Week	0	0	Every 2 weeks ±2 days
Day (approx.)	1	1	3	17	31	45	59	59 or 73
Informed Consent
Informed consent	X
Study procedures
Targeted physical exam (based on symptoms)	X	X	X	X	X	X	X	X
Vital signs	X	X	X	X	X	X	X	X
Past medical history
ECG	X		X					X
Concomitant medications	X
Demographics	X
Eligibility criteria	X
A:CR	X
Laboratory assessments
Baseline blood tests	X
iSTAT sK	X	X	X	X	X	X	X	X
Lab serum K	X	X	X	X	X	X	X	X
Laboratory safety assessment		X	X	X	X	X	X	X
Monitoring
AE/SAE assessment	Ongoing
Drug dosing and monitoring
LOKELMA/Placebo		X	X	X	X	X	X	X
RAASi		X	X	X	X	X	X	X
Diuretics use	X	X	X	X	X	X	X	X
Efficacy evaluations/Other assessments and assays
Quality of Life assessment	X							X
Hospitalization assessment		X	X	X	X	X	X	X
HF symptom assessment		X	X	X	X	X	X	X

Table 1—Study schedule of procedures. C6 (i.e. 7 visits total) will occur only in participants not prescribed RAASi at study entry. Baseline blood tests: serum haemoglobin, ferritin, urea, creatinine, sodium, potassium, BNP, troponin, calcium, phosphate, PTH. Laboratory safety assessment: serum sodium, potassium, creatinine

ISSN: 1471-2369