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

September 12, 2019 updated by: Sandoz

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • 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, France
        • Sandoz Investigative Site
  • Germany
      • 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, Germany
        • Sandoz Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Period 1: Advagraf®; Period 2: Generic tacrolimus
In Period 1 patients will receive branded tacrolimus (Advagraf®) orally once-a-day and in Period 2 patients will receive the generic tacrolimus (Sandoz) orally once-a-day.
Drug: Advagraf®
Advagraf®1 mg and 5 mg prolonged-release hard capsules once daily (reference medicinal product).
Drug: Generic tacrolimus
Tacrolimus 1 mg and 5 mg prolonged release hard capsules (Sandoz) once daily (test medicinal product)
Experimental: Period 1: Generic tacrolimus; Period 2: Advagraf®
In Period 1 patients will receive the generic tacrolimus (Sandoz) orally once-a-day and in Period 2 patients will receive branded tacrolimus (Advagraf®) orally once-a-day.
Drug: Advagraf®
Advagraf®1 mg and 5 mg prolonged-release hard capsules once daily (reference medicinal product).
Drug: Generic tacrolimus
Tacrolimus 1 mg and 5 mg prolonged release hard capsules (Sandoz) once daily (test medicinal product)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
AUC(0-τ)ss
Time Frame: Day 21 of each treatment period
Area under the whole blood concentration curve during a dosage interval (τ=24 hours) at steady state
Day 21 of each treatment period
Cmax,ss
Time Frame: Day 21 of each treatment period
Maximum whole blood concentration at steady state
Day 21 of each treatment period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
AUC(0-τ)ss
Time Frame: Day 14 of each treatment period
Area under the whole blood concentration curve during a dosage interval (τ=24 hours) at steady state
Day 14 of each treatment period
Cmax,ss
Time Frame: Day 14 of each treatment period
Maximum whole blood concentration at steady state
Day 14 of each treatment period
Cmin,ss
Time Frame: Days 14 and 21 of each treatment period
Minimum whole blood concentration at steady state
Days 14 and 21 of each treatment period
Cτ,ss
Time Frame: Days 14 and 21 of each treatment period
Concentration at the end of the dosing interval at steady state
Days 14 and 21 of each treatment period
Cav
Time Frame: Days 14 and 21 of each treatment period
Average concentration during a dosing interval: AUC(0-τ)/τ
Days 14 and 21 of each treatment period
Tmax,ss
Time Frame: Days 14 and 21 of each treatment period
Time to reach maximum (peak) plasma concentration at steady state
Days 14 and 21 of each treatment period
AUC(0-τ)ss coefficient of variation
Time Frame: Days 14 and 21 of each treatment period
Intra-patient pharmacokinetics variability evaluated by calculating AUC(0-τ)ss coefficient of variation
Days 14 and 21 of each treatment period
Cmax,ss coefficient of variation
Time Frame: Days 14 and 21 of each treatment period
Intra-patient pharmacokinetics variability evaluated by calculating Cmax,ss coefficient of variation
Days 14 and 21 of each treatment period
% Fluctuation
Time Frame: 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.
Days 14 and 21 of each treatment period
%Swing
Time Frame: 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.
Days 14 and 21 of each treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sandoz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 2, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 3, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 3, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 5, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 7, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 17, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1829-TAC-1
  • 2018-002672-40 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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