Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
To characterise the bioavailability of Envarsus® and compare it to the bioavailability of tacrolimus |
To characterise the PK profile of extended release tacrolimus (Envarsus®) in diabetic transplant recipients, and compare it to the PK profile of tacrolimus : bioavailability AUC0-24 |
Initial tacrolimus PK profile measurement: day 7-17 post SPK transplantation. Second ENVARSUS® PK profile measurement: day 15-32 post SPK transplantation |
|
Secondary |
Further quantification of the PK profile of extended release tacrolimus and Myfortic in patients with both functional grafts: Cmin |
Cmin |
Initial tacrolimus and myfortic PK profile measurement: day 7-17 post SPK transplantation. Second ENVARSUS® and Myfortic PK profile measurement: day 15-32 post SPK transplantation |
|
Secondary |
Further quantification of the PK profile of extended release tacrolimus and Myfortic in patients only with a functional kidney graft in case of early pancreas thrombosis.: Cmin |
Cmin |
Initial tacrolimus and myfortic PK profile measurement: day 7-17 post SPK transplantation. Second ENVARSUS® and Myfortic PK profile measurement: day 15-32 post SPK transplantation |
|
Secondary |
Further quantification of the PK profile of extended release tacrolimus and Myfortic in patients with both functional grafts : Cmax |
Cmax |
Initial tacrolimus and Myfortic PK profile measurement: day 7-17 post SPK transplantation. Second ENVARSUS® and Myfortic PK profile measurement: day 15-32 post SPK transplantation |
|
Secondary |
Further quantification of the PK profile of extended release tacrolimus and Myfortic in patients only with a functional kidney graft in case of early pancreas thrombosis.: Cmax |
Cmax |
Initial tacrolimus and Myfortic PK profile measurement: day 7-17 post SPK transplantation. Second ENVARSUS® and Myfortic PK profile measurement: day 15-32 post SPK transplantation |
|
Secondary |
Further quantification of the PK profile of extended release tacrolimus and Myfortic in patients with both functional grafts: Cavg |
Cavg |
Initial tacrolimus and Myfortic PK profile measurement: day 7-17 post SPK transplantation. Second ENVARSUS® and Myfortic PK profile measurement: day 15-32 post SPK transplantation |
|
Secondary |
Further quantification of the PK profile of extended release tacrolimus and Myforticin patients only with a functional kidney graft in case of early pancreas thrombosis.: Cavg |
Cavg |
Initial tacrolimus and Myfortic PK profile measurement: day 7-17 post SPK transplantation. Second ENVARSUS® and Myfortic PK profile measurement: day 15-32 post SPK transplantation |
|
Secondary |
Further quantification of the PK profile of extended release tacrolimus and Myfortic in patients with both functional grafts: Tmax |
Tmax |
Initial tacrolimus and Myfortic PK profile measurement: day 7-17 post SPK transplantation. Second ENVARSUS® and Myfortic PK profile measurement: day 15-32 post SPK transplantation |
|
Secondary |
Further quantification of the PK profile of extended release tacrolimus and Myfortic in patients only with a functional kidney graft in case of early pancreas thrombosis..: Tmax |
Tmax |
Initial tacrolimus and Myfortic PK profile measurement: day 7-17 post SPK transplantation. Second ENVARSUS® and Myfortic PK profile measurement: day 15-32 post SPK transplantation |
|
Secondary |
Further quantification of the PK profile of extended release tacrolimus and Myfortic in patients with both functional grafts : Ke |
Ke |
Initial tacrolimus and Myfortic PK profile measurement: day 7-17 post SPK transplantation. Second ENVARSUS® and Myfortic PK profile measurement: day 15-32 post SPK transplantation |
|
Secondary |
Further quantification of the PK profile of extended release tacrolimus and Myfortic in patients only with a functional kidney graft in case of early pancreas thrombosis.: Ke |
Ke |
Initial tacrolimus and Myfortic PK profile measurement: day 7-17 post SPK transplantation. Second ENVARSUS® and Myfortic PK profile measurement: day 15-32 post SPK transplantation |
|
Secondary |
Further quantification of the PK profile of extended release tacrolimus and Myfortic in patients with both functional grafts : t1/2 |
t1/2 |
Initial tacrolimus and Myfortic PK profile measurement: day 7-17 post SPK transplantation. Second ENVARSUS® and Myfortic PK profile measurement: day 15-32 post SPK transplantation |
|
Secondary |
Further quantification of the PK profile of extended release tacrolimus and Myfortic in patients only with a functional kidney graft in case of early pancreas thrombosis.: t1/2 |
t1/2 |
Initial tacrolimus and Myfortic PK profile measurement: day 7-17 post SPK transplantation. Second ENVARSUS® and Myfortic PK profile measurement: day 15-32 post SPK transplantation |
|
Secondary |
Further quantification of the PK profile of extended release tacrolimus and Myfortic in patients with both functional grafts: % fluctuation |
% fluctuation |
Initial tacrolimus and Myfortic PK profile measurement: day 7-17 post SPK transplantation. Second ENVARSUS® and Myfortic PK profile measurement: day 15-32 post SPK transplantation |
|
Secondary |
Further quantification of the PK profile of extended release tacrolimus and Myfortic in patients only with a functional kidney graft in case of early pancreas thrombosis: % fluctuation |
% fluctuation |
Initial tacrolimus and Myfortic PK profile measurement: day 7-17 post SPK transplantation. Second ENVARSUS® and Myfortic PK profile measurement: day 15-32 post SPK transplantation |
|
Secondary |
Assessment of biological and clinical tolerance/ safety: Incidence of serious adverse events |
Incidence of serious adverse events |
Months 6, or on leaving hospital if after 6 months (maximum one year after the inclusion) |
|