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OpenTrials
Completed

NCT Number: NCT02500212

Pharmacokinetic Study of ENVARSUS 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.

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Key information

Conditions

Organ or Tissue Transplant; Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Nephrology Department Hopital La Cavale Blanche, Brest, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

ENVARSUS®

Drug

ADVAGRAF®

Drug

Primary outcomes

  1. 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

Secondary outcomes

  1. Tacrolimus concentration 24 hours post-dose (C24hr) pg/mL

    Time frame: 24.0 hr post-dose

    Whole blood trough drug concentration 24hour post dose

  2. Serum creatinine (mg/dL)

    Time frame: before dosing

  3. estimated glomerular filtration rate (eGFR) mL/min;

    Time frame: before dosing

  4. Heart Rate, (beats per minute)

    Time frame: before dosing

  5. Qt (milliseconds)

    Time frame: before dosing

Sponsors and collaborators

Lead sponsor

Chiesi Farmaceutici S.p.A.

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 16, 2015
Registry last updated
Jul 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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