Phase 3
Completed N=50
Crossover Study to Compare PK of Once Daily LCP-Tacro Tablets to Generic Tacrolimus Capsules Twice Daily.
Source: ClinicalTrials.gov NCT01962922 ↗Enrolled (actual)
50
Serious AEs
7.0%
Results posted
Aug 2016
Primary outcomePrimary: Evaluation of AUC(0-24) for Envarsus XR and IR-Tac — 251.9; 247.9 ng*hr/mL
◆ Published Evidence
Established
86citations · ~11 / year
Results of ASERTAA, a Randomized Prospective Crossover Pharmacogenetic Study of Immediate-Release Versus Extended-Release Tacrolimus in African American Kidney Transplant Recipients.
Summary
Open label, prospective, single-center, randomized, two sequence, three period crossover study to compare the steady state pharmacokinetics of LCP-Tacro tables to generic tacrolimus capsules administered twice daily in stable African-American renal transplant patients.
Linked Publications
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Results of ASERTAA, a Randomized Prospective Crossover Pharmacogenetic Study of Immediate-Release Versus Extended-Release Tacrolimus in African American Kidney Transplant Recipients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Evaluation of AUC(0-24) for Envarsus XR and IR-Tac |
289.3; 230.3 | — |
| PRIMARY Evaluation of C(Max) for Envarsus XR and IR-Tac |
19.71; 26.31 | — |
| PRIMARY Evaluation of C(Min) for Envarsus XR and IR-Tac |
8.01; 6.62 | — |
Eligibility Criteria
Inclusion criteria
- Age ≥18-80 old, male or female
- African Americans
- Willing to give written informed consent and to comply with study visits and restrictions, including being able to speak, write and understand English
- Pt who have received a primary or secondary transplant
- Pt least 6 (six) mth post-transplant and on a stable dose of tacrolimus
- BMI ≥19
- Pt who are sero-positive for Hepatitis B or C positive may also be enrolled
- Pt maintained on concurrent immunosuppression with stable doses during screening
- Pt on a proton PPI remain on the same PPI formulation and dose during the PK portion of the study.
- During PK phase Only: Pt taking any medication that could interfere with tacrolimus blood levels, including prescription and over-the-counter medications, herbal or food supplements (including grapefruit, and pomegranate products), or medications must continue the same dose and are willing to continue the same dose/routine
- During PK phase Only: the patient is not scheduled to begin any new medication that could interfere with tacrolimus blood levels, including prescription and over-the-counter medications, herbal or food
Exclusion Criteria
- Evidence of acute rejection episode within the past three months
- Pt not Africa-American
- Recipients of organ transplants other than kidney
- Known to be HIV positive at transplant
- Pt with recurrent focal segmental glomerulosclerosis (FSGS)
- Pt with any severe medical condition (including infection) requiring acute or chronic treatment
- Pt with a positive DSA
- Pt with a positive BK virus results
- GFR 2.5 x ULN or evidence of severe liver disease
- Pt with WBC < to 2000/mm3 or ANC < to 1500 mm3 with PLT < 75,000/mm3 or HGB < 8 g/dl
- Pt with mental or physical conditions or known non-adherence
- Presence of intractable immunosuppressant complications of side effects resulting in dose adjustment of tacrolimus
- Exposed to investigational therapy within 30 days prior to enrollment
- No anticipated changes in the immunosuppressive regimen, other than those specified by the study protocol
- Pt with severe diabetic gastroparesis or other severe GI disturbances
- Pt who have underwent gastric banding or gastric bypass at any time pre or post-transplant
- Pregnant or nursing (lactating) women, or planning to become pregnant
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant who are unwilling to use a defined SOC of method
Data sourced from ClinicalTrials.gov (NCT01962922) and the linked publication. 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. Informational only — not medical advice.