Design and rationale of the ATHENA study – A 12-month, multicentre, prospective study evaluating the outcomes of a de novo everolimus-based regimen in combination with reduced cyclosporine or tacrolimus versus a standard regimen in kidney transplant patients: study protocol for a randomised controlled trial

Table 4 Assessment schedule

	12-month study period
Month	Baseline	1	3	6	9	Premature end of treatment/withdrawal	12
Visit	1	2	3	4	5	6	7
Enrolment
Informed consent	X
Inclusion/Exclusion	X
Randomisation	X
Demography	X
General medical history	X
Transplantation information	X
Viral serology	X
Pregnancy test (β-HCG)	X
Interventions
Trough levels (everolimus, cyclosporine, tacrolimus)		X	X	X	X	X	X
Assessments
Physical examination	X					X	X
Vital signs	X	X	X	X	X	X	X
Study medication check		X	X	X	X	X	X
Haematology/Biochemistry	X	X	X	X	X	X	X
Urinalysis		X	X	X	X	X	X
Viral assessments		X	X	X	X	X	X
Serum for non-HLA antibodies and DSA	X			X		X	X
Echocardiography (LVH)	X					X	X
Protocol renal allograft biopsy^a	X			X			X
Biomarker assessments^b	X	X				X	X
CMV substudy^b	X					X	X
Wound healing complications	As necessary
Rejection episodes
Indicated renal allograft biopsy
Dialysis
AEs/SAEs/Infections/Comments
Concomitant therapy
Immunosuppressive therapy
End of treatment						X	X
End of study						X	X

β-HCG human chorionic gonadotropin, AE adverse events, DSA donor-specific antibodies, HLA human leukocyte antigen, LVH left ventricular hypertrophy, SAE severe adverse events
^aNot mandatory. Can be performed according to centre practice
^bOnly in selected centres and patients

ISSN: 1745-6215