Study to Compare Pharmacokinetics of Tacrolimus Prolonged-release (PR) Capsules and Advagraf® PR Capsules in Stable Kidney Transplant Patients.

Kidney Transplant Clinical Trial

— TODAY  

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03978494
• Other study ID #: 1829-TAC-1
• Secondary ID: 2018-002672-40
• Status: Withdrawn
• Phase: Phase 1
• Start date: September 2, 2019
• Est. completion date: May 3, 2020

Study information

• Verified date: September 2019
• Source: Sandoz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Study to compare pharmacokinetics of tacrolimus prolonged-release (PR) capsules and Advagraf® PR capsules in stable kidney transplant patients.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 3, 2020
• Est. primary completion date: May 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Kidney Transplant

Intervention

Drug:
• Advagraf®
Advagraf®1 mg and 5 mg prolonged-release hard capsules once daily (reference medicinal product).
• Generic tacrolimus
Tacrolimus 1 mg and 5 mg prolonged release hard capsules (Sandoz) once daily (test medicinal product)

Locations

Country	Name	City	State
France	Sandoz Investigative Site	Grenoble
France	Sandoz Investigative Site	Limoges
France	Sandoz Investigative Site	Nantes
France	Sandoz Investigative Site	Strasbourg
France	Sandoz Investigative Site	Suresnes
France	Sandoz Investigative Site	Toulouse
France	Sandoz Investigative Site	Tours
Germany	Sandoz Investigative Site	Berlin
Germany	Sandoz Investigative Site	Bochum
Germany	Sandoz Investigative Site	Essen
Germany	Sandoz Investigative Site	Hannover
Germany	Sandoz Investigative Site	Kaiserslautern
Germany	Sandoz Investigative Site	Kiel

Sponsors (1)

Lead Sponsor	Collaborator
Sandoz

Countries where clinical trial is conducted

France,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC(0-t)ss	Area under the whole blood concentration curve during a dosage interval (t=24 hours) at steady state	Day 21 of each treatment period
Primary	Cmax,ss	Maximum whole blood concentration at steady state	Day 21 of each treatment period
Secondary	AUC(0-t)ss	Area under the whole blood concentration curve during a dosage interval (t=24 hours) at steady state	Day 14 of each treatment period
Secondary	Cmax,ss	Maximum whole blood concentration at steady state	Day 14 of each treatment period
Secondary	Cmin,ss	Minimum whole blood concentration at steady state	Days 14 and 21 of each treatment period
Secondary	Ct,ss	Concentration at the end of the dosing interval at steady state	Days 14 and 21 of each treatment period
Secondary	Cav	Average concentration during a dosing interval: AUC(0-t)/t	Days 14 and 21 of each treatment period
Secondary	Tmax,ss	Time to reach maximum (peak) plasma concentration at steady state	Days 14 and 21 of each treatment period
Secondary	AUC(0-t)ss coefficient of variation	Intra-patient pharmacokinetics variability evaluated by calculating AUC(0-t)ss coefficient of variation	Days 14 and 21 of each treatment period
Secondary	Cmax,ss coefficient of variation	Intra-patient pharmacokinetics variability evaluated by calculating Cmax,ss coefficient of variation	Days 14 and 21 of each treatment period
Secondary	% Fluctuation	Degree of fluctuation of the analyte concentration levels over one dosing interval: 100*(Cmax,ss - Cmin,ss)/Cav.	Days 14 and 21 of each treatment period
Secondary	%Swing	Degree of change of the analyte concentration levels over one dosing interval: 100*(Cmax,ss - Ct,ss)/Ct,ss.	Days 14 and 21 of each treatment period