Pharmacokinetic Comparison Of All FK-506 Formulations

Renal Failure Clinical Trial

— ASTCOFF  

Official title:

A Steady-state Pharmacokinetic Comparison Of All FK-506 Formulations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02339246
• Other study ID #: Envarsus 3006
• Status: Completed
• Phase: Phase 3
• First received: December 19, 2014
• Last updated: December 11, 2015
• Start date: January 2015
• Est. completion date: March 2015

Study information

• Verified date: November 2015
• Source: Veloxis Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Renal Failure

Intervention

Drug:
• Prograf vs Envarsus XR vs Astagraf XL
prograf vs Envarsus XR vs Astagraf XL
• Prograf vs Astagraf XL vs Envarsus XR
Prograf vs Astagraf XL vs Envarsus XR

Locations

Country	Name	City	State
United States	University of Cincinnati	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Veloxis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No