Phase 3
N=31
Pharmacokinetic Comparison Of All FK-506 Formulations
Renal Failure
Bottom Line
View on ClinicalTrials.gov: NCT02339246 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Jan 2016
Primary outcome: Primary: Evaluation of T(Max) for Envarsus XR, Astagraf XL and Prograf. — 5.91; 1.93; 1.48 hour
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Prograf vs Envarsus XR vs Astagraf XL (Drug); Prograf vs Astagraf XL vs Envarsus XR (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Veloxis Pharmaceuticals
- Primary completion
- Mar 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Evaluation of T(Max) for Envarsus XR, Astagraf XL and Prograf. |
5.91; 1.93; 1.48 | — |
| PRIMARY Evaluation of C(Max) for Envarsus XR, Astagraf XL and Prograf. |
13.88; 13.17; 14.54 | — |
| PRIMARY Evaluation of AUC(0-24) for Envarsus XR, Astagraf XL and Prograf. |
213.41; 165.02; 176.52 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02339246). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.