Pharmacokinetic Comparison Of All FK-506 Formulations
- Conditions
- Renal Failure
- Interventions
- Registration Number
- NCT02339246
- Lead Sponsor
- Veloxis Pharmaceuticals
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Prograf vs Astagraf XL vs Envarsus XR 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. Prograf vs Envarsus XR vs Astagraf XL 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.
- Primary Outcome Measures
Name Time Method Evaluation of T(Max) for Envarsus XR, Astagraf XL and Prograf. 8 days 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.Evaluation of C(Max) for Envarsus XR, Astagraf XL and Prograf. 8 days 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.Evaluation of AUC(0-24) for Envarsus XR, Astagraf XL and Prograf. 8 days 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States