Kidney Transplant
Conditions
Keywords
Kidney transplant; Renal transplant
Brief summary
Study to compare pharmacokinetics of tacrolimus prolonged-release (PR) capsules and Advagraf® PR capsules in stable kidney transplant patients.
Detailed description
Initially, patients will enter a short screening period, and those who continue to meet the inclusion and exclusion criteria will be randomized to receive either test or reference medicinal product in Period 1. In period 2 they will switch to the other formulation. During the whole treatment period four full-pharmacokinetics profiles will be established.
Interventions
DRUGAdvagraf®
Advagraf®1 mg and 5 mg prolonged-release hard capsules once daily (reference medicinal product).
Tacrolimus 1 mg and 5 mg prolonged release hard capsules (Sandoz) once daily (test medicinal product)
Sponsors
Sandoz
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female patients aged ≥18 years; * Patients with a Body Mass Index (BMI) included in the interval \[18.5-33.0\] kg/m²; * Patients who received a primary kidney transplant at least 12 months prior to study entry
Exclusion criteria
* Evidence or suspicion of ongoing or persistent, acute or chronic rejection; * Requirement for dialysis within the six months prior to study entry; * Glomerular filtration rate (GFR) \<30 mL/min * Pregnant or breastfeeding women, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test; * Intolerance to tacrolimus, excipients (including lactose, fructose or galactose), or similar products;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC(0-τ)ss | Day 21 of each treatment period | Area under the whole blood concentration curve during a dosage interval (τ=24 hours) at steady state |
| Cmax,ss | Day 21 of each treatment period | Maximum whole blood concentration at steady state |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cmax,ss | Day 14 of each treatment period | Maximum whole blood concentration at steady state |
| Cτ,ss | Days 14 and 21 of each treatment period | Concentration at the end of the dosing interval at steady state |
| Cav | Days 14 and 21 of each treatment period | Average concentration during a dosing interval: AUC(0-τ)/τ |
| Tmax,ss | Days 14 and 21 of each treatment period | Time to reach maximum (peak) plasma concentration at steady state |
| Cmin,ss | Days 14 and 21 of each treatment period | Minimum whole blood concentration at steady state |
| Cmax,ss coefficient of variation | Days 14 and 21 of each treatment period | Intra-patient pharmacokinetics variability evaluated by calculating Cmax,ss coefficient of variation |
| % Fluctuation | Days 14 and 21 of each treatment period | Degree of fluctuation of the analyte concentration levels over one dosing interval: 100\*(Cmax,ss - Cmin,ss)/Cav. |
| %Swing | Days 14 and 21 of each treatment period | Degree of change of the analyte concentration levels over one dosing interval: 100\*(Cmax,ss - Cτ,ss)/Cτ,ss. |
| AUC(0-τ)ss coefficient of variation | Days 14 and 21 of each treatment period | Intra-patient pharmacokinetics variability evaluated by calculating AUC(0-τ)ss coefficient of variation |
| AUC(0-τ)ss | Day 14 of each treatment period | Area under the whole blood concentration curve during a dosage interval (τ=24 hours) at steady state |
Countries
France, Germany
Outcome results
None listed