Table 3.

FIND-CKD study end points and safety evaluations

Efficacy end points	Safety evaluations
Primary end point	Clinical laboratory tests (haematology, serum chemistry, urinalysis, hormone levels)
Time to initiation of other anaemia management (e.g. ESA or transfusion)	Concomitant medication
Secondary end points	Adverse events, including severity and relationship to study medication
Cumulative ESA dose	Adverse events and serious adverse events leading to study withdrawal
Requirement for transfusion	Physical examination (unusual findings)
Cumulative iron dose and number of iron administrations	Vital signs (blood pressure, temperature, heart rate and body weight)
Increase of Hb ≥1 g/dL prior to any other anaemia management (e.g. ESA or transfusion)	Abnormal features on electrocardiogram
Change from baseline to end of study for haematological and iron parameters
Change from baseline to end of study for eGFR (MDRD formula)
Requirement for dialysis
Change in health-related quality of life from baseline to end of study (SF-36)
Health resource utilization over the study period (direct, indirect and total costs from payer's and societal perspective)
Cost effectiveness of treatment options using relevant effectiveness parameters
Percentage of subjects discontinuing the study drug due to intolerance

eGFR, estimated glomerular filtration rate; ESA, erythropoiesis-stimulating agent; MDRD, modification of diet in renal disease; SF-36, short-form health survey.