NCT02339246

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2015

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2014

Completed
13 days until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 15, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
11 months until next milestone

Results Posted

Study results publicly available

January 18, 2016

Completed
Last Updated

January 18, 2016

Status Verified

November 1, 2015

Enrollment Period

2 months

First QC Date

December 19, 2014

Results QC Date

November 6, 2015

Last Update Submit

December 11, 2015

Conditions

Renal Failure

Outcome Measures

Primary Outcomes (3)

  • 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.

    8 days

  • 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.

    8 days

  • 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.

    8 days

Study Arms (2)

Prograf vs Envarsus XR vs Astagraf XL

ACTIVE COMPARATOR

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 Astagraf XL vs Envarsus XR

ACTIVE COMPARATOR

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

Interventions

Prograf vs Envarsus XR vs Astagraf XLDRUG

prograf vs Envarsus XR vs Astagraf XL

Also known as: Tacrolimus
Prograf vs Envarsus XR vs Astagraf XL
Prograf vs Astagraf XL vs Envarsus XRDRUG

Prograf vs Astagraf XL vs Envarsus XR

Also known as: Tacrolimus
Prograf vs Astagraf XL vs Envarsus XR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45267-2827, United States

Location

Related Publications (2)

  • 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.

    PMID: 29462506DERIVED

  • 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.

    PMID: 27340950DERIVED

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Tacrolimus

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Results Point of Contact

Title
Christina Sylvest
Organization
Veloxis Pharmaceuticals
csy@veloxis.com
+4520553877

Study Officials

  • Rita Alloway, PharmD

    University of Cincinnati

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2014

First Posted

January 15, 2015

Study Start

January 1, 2015

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

January 18, 2016

Results First Posted

January 18, 2016

Record last verified: 2015-11

Locations

US(1)