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

NCT ID: NCT01666951

Last Updated: 2015-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2013-05-31

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.

Conditions

Renal Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

LCP-Tacro

LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)

Group Type: EXPERIMENTAL

LCP-Tacro tablets

Intervention Type: DRUG

Tacrolimus

Prograf

Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)

Group Type: ACTIVE_COMPARATOR

Prograf

Intervention Type: DRUG

Tacrolimus

Interventions

LCP-Tacro tablets

Tacrolimus

Intervention Type: DRUG

Prograf

Tacrolimus

Intervention Type: DRUG

Other Intervention Names

Prograf; Prograf Capsules twice daily

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Veloxis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William Polvino, MD

Role: STUDY_DIRECTOR

Veloxis Pharmaceuticals

Locations

Clinical Investigative Site 00001

Charlottesville, Virginia, United States

Clinical Investigative Site 000015

San Diego, California, United States

Clinical Investigative Site 000012

San Francisco, California, United States

Clinical Investigative Site 00004

Aurora, Colorado, United States

Clinical Investigative Site 000002

Tampa, Florida, United States

Clinical Investigative Site 000005

Lexington, Kentucky, United States

Clinical Investigative Site 000009

Ann Arbor, Michigan, United States

Clinical Investigative Site 000010

Livingston, New Jersey, United States

Clinical Investigative Site 000011

Buffalo, New York, United States

Clinical Investigative Site 00006

New York, New York, United States

Clinical Investigative Site 00008

Cleveland, Ohio, United States

Clinical Investigative Site 00003

Philadelphia, Pennsylvania, United States

Clinical Investigative Site 000013

Dallas, Texas, United States

Countries

United States

Other Identifiers

LCP-Tacro 2019

Identifier Type: -

Identifier Source: org_study_id