Pharmacokinetic Comparison Of All FK-506 Formulations (ASTCOFF)

Veloxis Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Renal Failure

Treatments: Drug: Prograf vs Astagraf XL vs Envarsus XR; Drug: Prograf vs Envarsus XR vs Astagraf XL

Study type: Interventional

Funder types: Industry

Identifiers

NCT02339246

Envarsus 3006

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Prograf vs Envarsus XR vs Astagraf XL

Active Comparator group

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.

Treatment:

Drug: Prograf vs Envarsus XR vs Astagraf XL

Prograf vs Astagraf XL vs Envarsus XR

Active Comparator group

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.

Treatment:

Drug: Prograf vs Astagraf XL vs Envarsus XR