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

Veloxis Pharmaceuticals

Status and phase

Completed

Phase 3

Conditions

Renal Failure

Treatments

Drug: LCP-Tacro

Drug: Tacrolimus -IR

Study type

Interventional

Funder types

Industry

Identifiers

NCT01962922

LCP-Tacro 3004

Details and patient eligibility

About

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.

Full description

This is open label, prospective, single-center, randomized, two sequence, three period crossover study to compare the steady state pharmacokinetics of once daily dosing of LCP-Tacro tablets to tacrolimus capsules administered twice daily in stable African American kidney transplant patients.

Approximately 72 male and female African American renal transplant patients on table immunosuppression regimens will be randomly assigned in a 1:1 ratio to one of two sequences:

Sequence 1: (n=36) 18 patients requiring less than 0.15 mg/kg/day and 18 patients requiring equal to or greater than 0.15 mg/kg/day. Patients will continue on generic tacrolimus capsules on days 1-7 (24 hours PK profile on day 7) then patients are switched to LCP-Tacro tablets (at 15% lower dose of twice daily generic tacrolimus) on day 8.

Sequence 2: (n=36) 18 patients requiring less than 0.15 mg/kg/day and 18 patients requiring equal to or greater than 0.15 mg/kg/day. Patients will receive LCP-Tacro tablets (at 15% lower dose than generic tacrolimus twice daily formulation) on days 1-7 (24 hour PK profile on day 7) patients are switched back to twice daily generic tacrolimus treatment beginning on day 8.

Enrollment

50 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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