Multicenter, Prospective, Rand, PK Study of LCP-Tacro™ Compared to Prograf® Capsules in De Novo Adult Kidney Transplant

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the pharmacokinetics of LCP-Tacro tablets administered once-daily compared to Prograf capsules administered twice-daily after kidney transplantation.

Detailed Description
-----------------
This is a 2-arm , parallel group, prospective, double-blind, double-dummy, multicenter,clinical trial to evaluate the pharmacokinetics of LCP-Tacro tablets once daily in comparison to Prograf capsules twice-daily after kidney transplantation.

Official Title
-----------------
Ph 2 Double-blind, Double-dummy, Multicenter, Prospective, Rand Study of PK of LCP-Tacro™ Tablets Once Daily, Compared to Prograf® Caps, Twice Daily, for Prevention of Acute Allograft Rejection in De Novo Adult Kidney Transplant Recipients

Conditions
-----------------
Renal Failure

Intervention / Treatment
-----------------
* Drug: LCP-Tacro tablets
* Drug: Prograf


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Give written consent Male and female subjects between the ages of 18 and 70 years, inclusive Must be receiving primary or secondary renal allograft from a deceased donor or non- HLA identical living donor WOCBP must have a negative pregnancy test Must have negative cross-match test and be ABO-compatible Must be able to swallow tablets and capsules Exclusion criteria Recipients of any previous nonrenal or concurrent transplant Have panel reactive antibody >50% Any condition that may affect study drug absorption BMI <18 kg/m2 or > 45 kg/m2 History of alcohol abuse with less than 6 months of sobriety History of recreational drug abuse with less than 6 months of documented abstinence Screening 12-lead ECG demonstrating CS abnormalities (including QTc prolongation) WOCBP and are either pregnant, lactating, planning to become pregnant or with a positive serum or urine pregnancy test Subjects (male or female) with reproductive potential who are unwilling/unable to use a double-barrier method Oral temperature (prior to study drug dosing) of 38.0ºC or higher CS active infections (eg, those requiring hospitalization, or as judged by the Investigator) Known hereditary immunodeficiency Malignancies or with a history of malignancies (within the last 5 years) with the exception of local, noninvasive, fully excised cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, or cervical carcinoma in situ Expect to receive within 2 months after randomization, or have received within 3 months prior to screening, any of the following: sirolimus, everolimus, belatacept, or cyclophosphamide Any psychiatric or medical condition that, in the Investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study Clinically symptomatic CHF or documented EJF of less than 45% Significant COPD, pulmonary restrictive disease or significant pulmonary hypertension Enrolled in another investigational drug or device study, or who are less than 30 days since discontinuing Laboratory variables that are abnormal (outside laboratory reference range) and CS Positive results of any of the following serological tests: human immunodeficiency virus (HIV)-1 antibody, hepatitis B virus (HBV) surface antigen (HBsAg), anti-hepatitis B core antibody (HBcAb), and anti-hepatitis C virus (HCV) antibody (HCV Ab) Subjects who have had primary focal segmental glomerulosclerosis Donor parameters must not include any of the following known conditions: Donor with positive serological test result for HIV-1, HBV or HCV Donor with history of malignant disease (current or historical) Cold ischemia time >30 hours Non-heart-beating donor

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LCP-Tacro<br>LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK) | Drug: LCP-Tacro tablets<br>* Tacrolimus<br>* Other names: Prograf;|
| Active Comparator: Prograf<br>Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL) | Drug: Prograf<br>* Tacrolimus<br>* Other names: Prograf Capsules twice daily;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (AUC) of LCP-Tacro Compared to Prograf After Kidney Transplantation | The pharmacokinetic parameter (AUC) was evaluated on Day 1 in adult de novo kidney recipients. Samples were collected from 0 to 24 hours post dose. | 1 days | 
| Pharmacokinetics (AUC) of LCP-Tacro Compared to Prograf After Kidney Transplantation | The pharmacokinetic parameter (AUC) was evaluated on Day 14 in adult de novo kidney recipients. Samples were collected from 0 to 24 hours post dose. | 14 days | 
| Pharmacokinetics (AUC) of LCP-Tacro Compared to Prograf After Kidney Transplantation | The pharmacokinetic parameter (AUC) was evaluated on Day 28 in adult de novo kidney recipients. Samples were collected from 0 to 24 hours post dose. | 28 days | 
| Pharmacokinetics (Cmax and C24) of LCP-Tacro Compared to Prograf After Kidney Transplantation | The pharmacokinetic parameter (Cmax and C24) was evaluated on Day 1 in adult de novo kidney recipients. | 1 days | 
| Pharmacokinetics (Cmax and C24) of LCP-Tacro Compared to Prograf After Kidney Transplantation | The pharmacokinetic parameter (Cmax and C24) was evaluated on Day 14 in adult de novo kidney recipients. | 14 days | 
| Pharmacokinetics (Cmax and C24) of LCP-Tacro Compared to Prograf After Kidney Transplantation | The pharmacokinetic parameter (Cmax and C24) was evaluated on Day 28 in adult de novo kidney recipients. | 28 days | 
| Pharmacokinetics (Tmax) of LCP-Tacro Compared to Prograf After Kidney Transplantation | The pharmacokinetic parameter (Tmax) was evaluated on Day 1 in adult de novo kidney recipients. | 1 days | 
| Pharmacokinetics (Tmax) of LCP-Tacro Compared to Prograf After Kidney Transplantation | The pharmacokinetic parameter (Tmax) was evaluated on Day 14 in adult de novo kidney recipients. | 14 days | 
| Pharmacokinetics (Tmax) of LCP-Tacro Compared to Prograf After Kidney Transplantation | The pharmacokinetic parameter (Tmax) was evaluated on Day 28 in adult de novo kidney recipients. | 28 days | 
| Pharmacokinetics (Fluctuation) of LCP-Tacro Compared to Prograf After Kidney Transplantation | The pharmacokinetic parameter (Fluctuation) was evaluated on Day 14 in adult de novo kidney recipients. | 14 days | 
| Pharmacokinetics (Fluctuation) of LCP-Tacro Compared to Prograf After Kidney Transplantation | The pharmacokinetic parameter (Fluctuation) was evaluated on Day 28 in adult de novo kidney recipients. | 28 days |