Crossover Study to Compare PK of Once Daily LCP-Tacro Tablets to Generic Tacrolimus Capsules Twice Daily.

• Status: Completed
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Veloxis Pharmaceuticals
• Treatments: Tacrolimus

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 < 25 ml/min measured by MDRD4 as SOC within last 30 days

• Patients with AST, ALT, total bilirubin > 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