Pharmacokinetic Comparison Of All FK-506 Formulations

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-03-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Renal Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Prograf vs Envarsus XR vs Astagraf XL

Intervention Type DRUG

prograf vs Envarsus XR vs Astagraf XL

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.

Group Type ACTIVE_COMPARATOR

Prograf vs Astagraf XL vs Envarsus XR

Intervention Type DRUG

Prograf vs Astagraf XL vs Envarsus XR

Interventions

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Prograf vs Envarsus XR vs Astagraf XL

prograf vs Envarsus XR vs Astagraf XL

Intervention Type DRUG

Prograf vs Astagraf XL vs Envarsus XR

Intervention Type DRUG

Other Intervention Names

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Tacrolimus Tacrolimus

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No