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

Phase 3

Completed

• Conditions: Renal Failure
• Interventions: Drug: Tacrolimus -IR; Drug: LCP-Tacro

• Registration Number: NCT01962922
• Lead Sponsor: Veloxis Pharmaceuticals

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2013-10-08
• Study First Submitted QC: 2013-10-10
• Study First Posted: 2013-10-14
• Study Start: 2013-11
• Primary Completion: 2015-07
• Study Completion: 2015-08
• Results First Submitted: 2016-02-23
• Results First Submitted QC: 2016-07-05
• Results First Posted: 2016-08-15
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-02
• Last Update Posted: 2018-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Tacrolimus - IR	Tacrolimus -IR	Tacrolimus
LCP-Tacro	LCP-Tacro	Envarsus XR

Primary Outcome Measures

Name	Time	Method
Evaluation of AUC(0-24) for Envarsus XR and IR-Tac	Day 21	Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate AUC(0-24). Arithmetic mean and standard deviation is given below.; Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours.
Evaluation of C(Max) for Envarsus XR and IR-Tac	Day 21	Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate C(max). Arithmetic mean and standard deviation is given below.; Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours.
Evaluation of C(Min) for Envarsus XR and IR-Tac	Day 21	Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate AUC(0-24). Arithmetic mean and standard deviation is given below.; Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours.

Trial Locations

Locations (3)

Washingto University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States

University of Illinois, Chicago; 🇺🇸 Chicago, Illinois, United States

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States