Organ or Tissue Transplant; Complications
Conditions
Brief summary
Open-label, multicentre, randomized clinical trial to compare the pharmacokinetics of ENVARSUS® tablets and ADVAGRAF® capsules administered once daily in adult de-novo kidney transplant patients.
Sponsors
Chiesi Farmaceutici S.p.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Recipients of a kidney transplant from a deceased donor or a living donor
Exclusion criteria
* Recipient of any transplanted organ other than a kidney; * Recipients of a bone marrow or stem cell transplant; * Recipients of a kidney from a cardiac death donor; * Recipients of a kidney from an ABO incompatible donor;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tacrolimus Area under the curve (AUC 0-24h)r h*pg/mL | pre-dose, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12.0, 16.0, 20.0, 24.0 hr post-dose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tacrolimus concentration 24 hours post-dose (C24hr) pg/mL | 24.0 hr post-dose | Whole blood trough drug concentration 24hour post dose |
| Serum creatinine (mg/dL) | before dosing | — |
| estimated glomerular filtration rate (eGFR) mL/min; | before dosing | — |
| Heart Rate, (beats per minute) | before dosing | — |
| Qt (milliseconds) | before dosing | — |
Countries
France
Outcome results
None listed