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

Veloxis Pharmaceuticals

Status and phase

Completed

Phase 2

Conditions

Renal Failure

Treatments

Drug: Prograf

Drug: LCP-Tacro tablets

Study type

Interventional

Funder types

Industry

Identifiers

NCT01666951

LCP-Tacro 2019

Details and patient eligibility

About

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.

Full 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.

Enrollment

36 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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