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Completed

NCT Number: NCT02339246

Pharmacokinetic Comparison Of All FK-506 Formulations

The purpose of the study is to compare the pharmacokinetic parameters of three different formulations of tacrolimus.

Eligible patients will be treated with all three formulations in a pre-defined sequence.

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Key information

Conditions

Renal Failure Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Cincinnati

Cincinnati, Ohio, 45267-2827, United States

About this study

The pharmacokinetic parameters T(max), C(max) and AUC(0-24) will be compared between the three formulations Envarsus XR once daily, Astagraf XL once daily and Prograf Twice daily.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Renal transplant recipients, males or females, of 18 years of age or above.
  • Able to participate and willing to give written informed consent and to comply with study visits and restrictions.
  • Able to understand English.
  • Patients having received a primary or secondary renal transplant

Exclusion criteria

  • Evidence of acute rejection episode within the past three months prior to screening.
  • Recipients of organ transplants other than kidney.
  • Patients who are known to be HIV positive.

Treatment and study plan

Prograf vs Envarsus XR vs Astagraf XL

Drug

prograf vs Envarsus XR vs Astagraf XL

Other names: Tacrolimus

Prograf vs Astagraf XL vs Envarsus XR

Drug

Prograf vs Astagraf XL vs Envarsus XR

Other names: Tacrolimus

Primary outcomes

  1. Evaluation of T(Max) for Envarsus XR, Astagraf XL and Prograf.

    Time frame: 8 days

    Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling times was used to calculate T(max).

    Nominal time points used were:

    Prograf sampling strategy (21 samples): Pre-dose (C0) and then 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20, and 24.

    Envarsus XR sampling strategy (18 samples): Pre-dose (C0) and then 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 18, 21, 24, and 27.

    Astagraf XL sampling strategy (17 samples): Pre-dose (C0) and then 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 18, 21, and 24.

  2. Evaluation of C(Max) for Envarsus XR, Astagraf XL and Prograf.

    Time frame: 8 days

    Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling times was used to calculate C(max).

    Nominal time points used were:

    Prograf sampling strategy (21 samples): Pre-dose (C0) and then 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20, and 24.

    Envarsus XR sampling strategy (18 samples): Pre-dose (C0) and then 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 18, 21, 24, and 27.

    Astagraf XL sampling strategy (17 samples): Pre-dose (C0) and then 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 18, 21, and 24.

  3. Evaluation of AUC(0-24) for Envarsus XR, Astagraf XL and Prograf.

    Time frame: 8 days

    Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling times was used to calculate AUC(0-24).

    Nominal time points used were:

    Prograf sampling strategy (21 samples): Pre-dose (C0) and then 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20, and 24.

    Envarsus XR sampling strategy (18 samples): Pre-dose (C0) and then 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 18, 21, 24, and 27.

    Astagraf XL sampling strategy (17 samples): Pre-dose (C0) and then 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 18, 21, and 24.

Sponsors and collaborators

Lead sponsor

Veloxis Pharmaceuticals

Industry

Registry information

Official study title

A Steady-state Pharmacokinetic Comparison Of All FK-506 Formulations

Acronym: ASTCOFF

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jan 15, 2015
Registry last updated
Jan 18, 2016

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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