Clinical trial NCT03978494: Study to Compare Pharmacokinetics of Tacrolimus Prolonged-release (PR) Capsules and Advagraf® PR Capsules in Stable Kidney Transplant Patients.
Official title: Randomized, Multicenter, Open-Label, Two-period, Two-sequence Crossover Comparative Pharmacokinetic Study of Generic Tacrolimus (Sandoz) and Advagraf® in Stable Renal Transplant Patients (TODAY)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Kidney Transplant
Keywords: Kidney transplant; Renal transplant
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2019-06-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

Eligibility criteria: 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;

Primary outcomes:
measure: AUC(0-τ)ss
timeFrame: Day 21 of each treatment period
measure: Cmax,ss
timeFrame: Day 21 of each treatment period
Secondary outcomes:
measure: AUC(0-τ)ss
timeFrame: Day 14 of each treatment period
measure: Cmax,ss
timeFrame: Day 14 of each treatment period
measure: Cmin,ss
timeFrame: Days 14 and 21 of each treatment period
measure: Cτ,ss
timeFrame: Days 14 and 21 of each treatment period
measure: Cav
timeFrame: Days 14 and 21 of each treatment period
measure: Tmax,ss
timeFrame: Days 14 and 21 of each treatment period
measure: AUC(0-τ)ss coefficient of variation
timeFrame: Days 14 and 21 of each treatment period
measure: Cmax,ss coefficient of variation
timeFrame: Days 14 and 21 of each treatment period
measure: % Fluctuation
timeFrame: Days 14 and 21 of each treatment period
measure: %Swing
timeFrame: Days 14 and 21 of each treatment period
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Sandoz Investigative Site
city: Limoges
country: France
facility: Sandoz Investigative Site
city: Nantes
country: France
facility: Sandoz Investigative Site
city: Strasbourg
country: France
facility: Sandoz Investigative Site
city: Suresnes
country: France
facility: Sandoz Investigative Site
city: Toulouse
country: France
facility: Sandoz Investigative Site
city: Tours
country: France
facility: Sandoz Investigative Site
city: Berlin
country: Germany
facility: Sandoz Investigative Site
city: Bochum
country: Germany
facility: Sandoz Investigative Site
city: Essen
country: Germany
facility: Sandoz Investigative Site
city: Hannover
country: Germany
facility: Sandoz Investigative Site
city: Kaiserslautern
country: Germany
facility: Sandoz Investigative Site
city: Kiel
country: Germany
facility: Sandoz Investigative Site
Study officials:
affiliation: Sandoz
name: Sandoz
role: STUDY_DIRECTOR
References: