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

Completed · Phase 2

Conditions studied: Renal Failure

In brief

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.

Key facts

Study ID

NCT01666951

Run by

Veloxis Pharmaceuticals

People needed

36

Starts

2012-11-01

Expected to finish

2013-05-01

Last updated by the study team

2015-07-07

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Clinical Investigative Site 00001 — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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