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Pharmacokinetic Comparison Of All FK-506 Formulations (ASTCOFF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02339246
Recruitment Status : Completed
First Posted : January 15, 2015
Results First Posted : January 18, 2016
Last Update Posted : January 18, 2016
Sponsor:
Information provided by (Responsible Party):
Veloxis Pharmaceuticals

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Renal Failure Drug: Prograf vs Envarsus XR vs Astagraf XL Drug: Prograf vs Astagraf XL vs Envarsus XR Phase 3

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Steady-state Pharmacokinetic Comparison Of All FK-506 Formulations
Study Start Date : January 2015
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus

Arm Intervention/treatment
Active Comparator: Prograf vs Envarsus XR vs Astagraf XL
Prograft capsules Twice daily for 7 days, followed by Envarsus XR tablets once daily for 7 days followed by Astagraf XL capsules once daily for 7 days.
Drug: Prograf vs Envarsus XR vs Astagraf XL
prograf vs Envarsus XR vs Astagraf XL
Other Name: Tacrolimus

Active Comparator: Prograf vs Astagraf XL vs Envarsus XR
Prograf capsules twice daily for 7 days followed by Astagraf XL capsules once daily for 7 days followed by Envarsus XR tablets once daily.
Drug: Prograf vs Astagraf XL vs Envarsus XR
Prograf vs Astagraf XL vs Envarsus XR
Other Name: Tacrolimus




Primary Outcome Measures :
  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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02339246


Locations
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United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267-2827
Sponsors and Collaborators
Veloxis Pharmaceuticals
Investigators
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Principal Investigator: Rita Alloway, PharmD University of Cincinnati
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Veloxis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02339246    
Other Study ID Numbers: Envarsus 3006
First Posted: January 15, 2015    Key Record Dates
Results First Posted: January 18, 2016
Last Update Posted: January 18, 2016
Last Verified: November 2015
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Diseases
Urologic Diseases
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action