| STUDY PERIOD | |||
---|---|---|---|---|
PHASE | Baseline | Post-allocation | End of study | |
Visit | 1 | 2 | 3 | 4 |
Day | 0 | Â | Â | Â |
Month |  | 1 ± 7d | 3 ± 14d | 6 ± 14d |
ENROLMENT | Â | Â | Â | Â |
Eligibility screen | x | Â | Â | Â |
Inclusion/exclusion | x | Â | Â | Â |
Randomisation (allocation) | x | Â | Â | Â |
INTERVENTIONS | Â | Â | Â | Â |
Intervention A (control group): adaption of CsA according to CsA C0 | x | x | x | Â |
Intervention B (investigational group): adaption of CsA according to NFAT-expression | x | x | x | Â |
ASSESSMENTS | Â | Â | Â | Â |
Demography | x | Â | Â | Â |
General medical history | x | Â | Â | Â |
Transplantation information | x | Â | Â | Â |
Physical examination | x | Â | Â | x |
Vital signs | x | x | x | x |
Study medication check | Â | x | x | x |
Laboratory test: | Â | Â | Â | Â |
 Hematocrit/Biochemistry |  |  |  |  |
  basic program |  | x | x |  |
  extended program | x |  |  | x |
 Urinanalysis | x |  |  | x |
 CsA C0 and C2 levels | x | x | x | x |
 NFAT-regulated gene expression | x | x | x | x |
Pulse wave velocity | x | Â | x | x |
Rejection episodes | as necessary | |||
Renal biopsy | as necessary | |||
Adverse events | as necessary | |||
Severe adverse events | as necessary | |||
Comments | as necessary | |||
Concomitant therapy | as necessary | |||
Immunosuppressive therapy | x | x | x | x |
Framingham score | x | Â | Â | x |
Quality of life assessment | x | Â | Â | x |