Pharmacokinetic Study of ENVARSUS in Adult De-novo Kidney Transplant Patients

July 30, 2020 updated by: Chiesi Farmaceutici S.p.A.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Phase 4

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
      • Brest, France, 296009
        • Nephrology Department Hopital La Cavale Blanche
      • Grenoble, France, 38043
        • Clinique de Nephrologie CHU Grenoble
      • Limoges, France, 87042
        • Chu Limoges
      • Montpellier, France, 34295
        • Service de néphrologie
      • Nice, France
        • Unité de transplantation rénale -Hopital Pasteur
      • Saint Etienne, France, 42055
        • Nephrology department CHU de Saint-Etienne Hospital Nord
      • Toulouse, France, 31400
        • CHU Rangueil, 1 avenue J Poulhes TSA 50032.

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

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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;

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ENVARSUS tablets

Envarsus® (tacrolimus) prolonged-release tablets provided in 0.75 mg, 1.0 mg and 4.0 mg dose strengths.

Envarsus® tablets will be administered orally once daily in the morning
Drug: ENVARSUS®
Active Comparator: ADVAGRAF capsules

Advagraf® (tacrolimus) prolonged-release hard capsules provided in 0.5 mg, 1.0 mg, 3.0 mg and 5.0 mg dose strengths.

Advagraf® capsules will be administered orally once daily in the morning
Drug: ADVAGRAF®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Tacrolimus Area under the curve (AUC 0-24h)r h*pg/mL
Time Frame: 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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tacrolimus concentration 24 hours post-dose (C24hr) pg/mL
Time Frame: 24.0 hr post-dose
Whole blood trough drug concentration 24hour post dose
24.0 hr post-dose
Serum creatinine (mg/dL)
Time Frame: before dosing
before dosing
estimated glomerular filtration rate (eGFR) mL/min;
Time Frame: before dosing
before dosing
Heart Rate, (beats per minute)
Time Frame: before dosing
before dosing
Qt (milliseconds)
Time Frame: before dosing
before dosing

Collaborators and Investigators

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

Sponsor

Chiesi Farmaceutici S.p.A.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

July 1, 2015

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

July 7, 2015

First Submitted That Met QC Criteria

July 15, 2015

First Posted (Estimate)

July 16, 2015

Study Record Updates

Last Update Posted (Actual)

July 31, 2020

Last Update Submitted That Met QC Criteria

July 30, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCD-06235AA1-02
  • 2014-005572-28 (EudraCT Number)

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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