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Pharmacokinetic Comparison Of All FK-506 Formulations (ASTCOFF)

Primary Purpose

Renal Failure

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Prograf vs Envarsus XR vs Astagraf XL
Prograf vs Astagraf XL vs Envarsus XR
Sponsored by
Veloxis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Renal Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Cincinnati

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Prograf vs Envarsus XR vs Astagraf XL

Prograf vs Astagraf XL vs Envarsus XR

Arm Description

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.

Prograf capsules twice daily for 7 days followed by Astagraf XL capsules once daily for 7 days followed by Envarsus XR tablets once daily.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 19, 2014
Last Updated
December 11, 2015
Sponsor
Veloxis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02339246
Brief Title
Pharmacokinetic Comparison Of All FK-506 Formulations
Acronym
ASTCOFF
Official Title
A Steady-state Pharmacokinetic Comparison Of All FK-506 Formulations
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Veloxis Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Failure

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prograf vs Envarsus XR vs Astagraf XL
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Prograf vs Astagraf XL vs Envarsus XR
Arm Type
Active Comparator
Arm Description
Prograf capsules twice daily for 7 days followed by Astagraf XL capsules once daily for 7 days followed by Envarsus XR tablets once daily.
Intervention Type
Drug
Intervention Name(s)
Prograf vs Envarsus XR vs Astagraf XL
Other Intervention Name(s)
Tacrolimus
Intervention Description
prograf vs Envarsus XR vs Astagraf XL
Intervention Type
Drug
Intervention Name(s)
Prograf vs Astagraf XL vs Envarsus XR
Other Intervention Name(s)
Tacrolimus
Intervention Description
Prograf vs Astagraf XL vs Envarsus XR
Primary Outcome Measure Information:
Title
Evaluation of T(Max) for Envarsus XR, Astagraf XL and Prograf.
Description
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.
Time Frame
8 days
Title
Evaluation of C(Max) for Envarsus XR, Astagraf XL and Prograf.
Description
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.
Time Frame
8 days
Title
Evaluation of AUC(0-24) for Envarsus XR, Astagraf XL and Prograf.
Description
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.
Time Frame
8 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rita Alloway, PharmD
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-2827
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29462506
Citation
Philosophe B, Leca N, West-Thielke PM, Horwedel T, Culkin-Gemmell C, Kistler K, Stevens DR. Evaluation of Flexible Tacrolimus Drug Concentration Monitoring Approach in Patients Receiving Extended-Release Once-Daily Tacrolimus Tablets. J Clin Pharmacol. 2018 Jul;58(7):891-896. doi: 10.1002/jcph.1082. Epub 2018 Feb 20.
Results Reference
derived
PubMed Identifier
27340950
Citation
Tremblay S, Nigro V, Weinberg J, Woodle ES, Alloway RR. A Steady-State Head-to-Head Pharmacokinetic Comparison of All FK-506 (Tacrolimus) Formulations (ASTCOFF): An Open-Label, Prospective, Randomized, Two-Arm, Three-Period Crossover Study. Am J Transplant. 2017 Feb;17(2):432-442. doi: 10.1111/ajt.13935. Epub 2016 Aug 2.
Results Reference
derived

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Pharmacokinetic Comparison Of All FK-506 Formulations

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