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CompletedNCT02339246ASTCOFFUpdated Jan 18, 2016Results posted

Pharmacokinetic Comparison Of All FK-506 Formulations

A Phase 3 interventional study of Prograf vs Envarsus XR vs Astagraf XL and Prograf vs Astagraf XL vs Envarsus XR in Renal Failure, sponsored by Veloxis Pharmaceuticals. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-01-18.

Sponsored by Veloxis Pharmaceuticals · Phase 3, Interventional, and Basic science

Phase
Phase 3
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Renal Failure

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03

In context

Renal Insufficiency

1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.

This study's enrollment of 32 is below the median of 43 across 1,504 interventional studies indexed under Renal Insufficiency.

Browse Renal Insufficiency studies →

Lead sponsor

Veloxis Pharmaceuticals is the lead sponsor of 18 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
32 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DrugPrograf vs Envarsus XR vs Astagraf XL

    prograf vs Envarsus XR vs Astagraf XL

    Also known as: Tacrolimus

  • DrugPrograf vs Astagraf XL vs Envarsus XR

    Prograf vs Astagraf XL vs Envarsus XR

    Also known as: Tacrolimus

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 8 days

  2. 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.

    Time frame: 8 days

  3. 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.

    Time frame: 8 days

07

Results

Posted Jan 18, 2016

Participant flow

32 patients were screened (enrolled) and 31 were randomized to treatment.

First Intervention (7 Days)
Participant flow — First Intervention (7 Days)
MilestoneEnvarsus XRAstagraf XLPrograf
Started0031
Completed0031
Not completed000
Second Intervention (7 Days)
Participant flow — Second Intervention (7 Days)
MilestoneEnvarsus XRAstagraf XLPrograf
Started16150
Completed16150
Not completed000
Third Period (7 Days)
Participant flow — Third Period (7 Days)
MilestoneEnvarsus XRAstagraf XLPrograf
Started15160
Completed15160
Not completed000

Outcome measures

PrimaryEvaluation 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.

Time frame:
8 days
Reported as:
Median · hour
Evaluation of T(Max) for Envarsus XR, Astagraf XL and Prograf.
hourEnvarsus XRAstagraf XLPrograf
Evaluation of T(Max) for Envarsus XR, Astagraf XL and Prograf.5.91 (1.45 to 13.95)1.93 (0.92 to 5.92)1.48 (0.93 to 19.97)
PrimaryEvaluation 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.

Time frame:
8 days
Reported as:
Mean · ng/mL
Evaluation of C(Max) for Envarsus XR, Astagraf XL and Prograf.
ng/mLEnvarsus XRAstagraf XLPrograf
Evaluation of C(Max) for Envarsus XR, Astagraf XL and Prograf.13.88 ± 5.33113.17 ± 12.4914.54 ± 13.60
PrimaryEvaluation 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.

Time frame:
8 days
Reported as:
Mean · hr*ng/mL
Evaluation of AUC(0-24) for Envarsus XR, Astagraf XL and Prograf.
hr*ng/mLEnvarsus XRAstagraf XLPrograf
Evaluation of AUC(0-24) for Envarsus XR, Astagraf XL and Prograf.213.41 ± 83.095165.02 ± 48.910176.52 ± 50.799

Adverse events

Collected over Adverse events were collected from time of first dose of study drug and until last visit which was approximately 1 month.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Envarsus XR—0/31 (0%)2/31 (6.5%)
Astagraf XR—0/31 (0%)10/31 (32.3%)
Prograf—0/31 (0%)3/31 (9.7%)
Most frequent other events
Most frequent other events
EventEnvarsus XRAstagraf XRPrograf
Oedema peripheralGeneral disorders0/313/310/31
DiarrheaGastrointestinal disorders0/312/311/31
VomitingGastrointestinal disorders0/312/310/31
FatigueGeneral disorders2/310/310/31
NasopharyngitisInfections and infestations0/312/310/31
HeadacheNervous system disorders0/311/312/31

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Prograf vs Envarsus XR vs Astagraf XLPrograf vs Astagraf XL vs Envarsus XRTotal
<=18 years000
Between 18 and 65 years151429
>=65 years112
Age, Continuous
Age, Continuous(years)Prograf vs Envarsus XR vs Astagraf XLPrograf vs Astagraf XL vs Envarsus XRTotal
Mean50.1 ± 11.0046.3 ± 13.3048.3 ± 12.11
Sex: Female, Male
Sex: Female, Male(Participants)Prograf vs Envarsus XR vs Astagraf XLPrograf vs Astagraf XL vs Envarsus XRTotal
Female7613
Male9918
Region of Enrollment
Region of Enrollment(participants)Prograf vs Envarsus XR vs Astagraf XLPrograf vs Astagraf XL vs Envarsus XRTotal
United States161531
08

Study locations

1 site
  • University of Cincinnati
    Cincinnati, Ohio 45267-2827, United States
09

References and documents

Publications

  • 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. PubMed 29462506 ↗
  • 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. PubMed 27340950 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 18, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02339246
Lead sponsor
Veloxis Pharmaceuticals
Responsible party
Sponsor
First posted
Jan 15, 2015
Start date
Jan 2015
Primary completion
Mar 2015
Completion
Mar 2015
Results posted
Jan 18, 2016
Last update
Jan 18, 2016

Study contacts

Rita Alloway, PharmD
principal investigator · University of Cincinnati

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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