Table 2 Flow chart of study visits

Visits

1

2

3

4

4

6-14

8

14

15-20

20

Informed consent¹

X

Randomization

X

Inclusion/exclusion criteria

X

Medical history

X

Transplantation

X

Pregnancy test as appropriate²

X

Vital signs (weight, blood pressure, pulse)

X

X

X

X

X

X

X

X

X

X

Height

X

X

X

X

X

X

X

X

Hematology (including differential count)

X

X

X

X

X

X

X

X

X

X

Chemistry panel (bilirubine., SGOT, SGPT, yGT, GlDH, CK, LDH)³

X

(X)

X

(X)

X

Lipid profile (cholesterol, LDL, HDL, triglycerides)

X

X

X

X

Serum creatinine, urea

X

X

X

X

X

X

X

X

X

X

Urine analysis (sticks, quantitative urine albumin and creatinine)

X

X

X

X

X

X

X

X

X

X

Trough level of CsA⁴

X

X

X

X

X

X

X

X

X

X

Trough level of everolimus⁴

X

X

X

X

X

X

X

X

X

X

CMV-, ADV-, HSV-specific T cells⁵

X

X

X

X

X

X

X

X

X

X

CMV, HSV, EBV IgG, IgM

X

X

X

X

X

X

X

X

X

X

CMV, ADV, EBV HSV-PCR

X

X

X

X

X

X

X

X

X

X

Clinical assessment

X

X

X

X

X

X

X

X

X

Protocol biopsy

X

X

X

X

X

X

X

CsA half dose and start everolimus

X

X

X

X

X

X

X

Start of steroid elimination

X

X

X

X

X

X

X

Treatment of rejection⁶

X

X

X

X

X

X

X

(X)

(X)

(X)

Prior/concomitant medications

X

X

X

X

X

X

X

X

X

X

Adverse events

X

X

X

X

X

X

X

X

X

X

X