Pharmacokinetic Comparison Of All FK-506 Formulations
| Status: | Completed |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | January 2015 |
| End Date: | March 2015 |
A Steady-state Pharmacokinetic Comparison Of All FK-506 Formulations
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.
formulations of tacrolimus.
Eligible patients will be treated with all three formulations in a pre-defined sequence.
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.
three formulations Envarsus XR once daily, Astagraf XL once daily and Prograf Twice daily.
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.
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