Clinical trial NCT01666951: Multicenter, Prospective, Rand, PK Study of LCP-Tacro™ Compared to Prograf® Capsules in De Novo Adult Kidney Transplant
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Renal Failure
Lead sponsor: Veloxis Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2012-08-16
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pharmacokinetics (AUC) of LCP-Tacro Compared to Prograf After Kidney Transplantation
timeFrame: 1 days
measure: Pharmacokinetics (AUC) of LCP-Tacro Compared to Prograf After Kidney Transplantation
timeFrame: 14 days
measure: Pharmacokinetics (AUC) of LCP-Tacro Compared to Prograf After Kidney Transplantation
timeFrame: 28 days
measure: Pharmacokinetics (Cmax and C24) of LCP-Tacro Compared to Prograf After Kidney Transplantation
timeFrame: 1 days
measure: Pharmacokinetics (Cmax and C24) of LCP-Tacro Compared to Prograf After Kidney Transplantation
timeFrame: 14 days
measure: Pharmacokinetics (Cmax and C24) of LCP-Tacro Compared to Prograf After Kidney Transplantation
timeFrame: 28 days
measure: Pharmacokinetics (Tmax) of LCP-Tacro Compared to Prograf After Kidney Transplantation
timeFrame: 1 days
measure: Pharmacokinetics (Tmax) of LCP-Tacro Compared to Prograf After Kidney Transplantation
timeFrame: 14 days
measure: Pharmacokinetics (Tmax) of LCP-Tacro Compared to Prograf After Kidney Transplantation
timeFrame: 28 days
measure: Pharmacokinetics (Fluctuation) of LCP-Tacro Compared to Prograf After Kidney Transplantation
timeFrame: 14 days
measure: Pharmacokinetics (Fluctuation) of LCP-Tacro Compared to Prograf After Kidney Transplantation
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
measure: Daytime, Nighttime and Overnight Systolic Blood Pressure (SBP) on Day 14.
timeFrame: 14 days
measure: Daytime, Nighttime Overnight Systolic Blood Pressure (SBP) on Day 28.
timeFrame: 28 days
measure: Ratio of Nighttime to Daytime Systolic Blood Pressure (SBP) on Day 14.
timeFrame: 14 days
measure: Ratio of Nighttime to Daytime Systolic Blood Pressure (SBP) on Day 28.
timeFrame: 28 days
measure: Evaluation of the Short-term Efficacy of LCP-Tacro After the Start of Dosing.
timeFrame: 30 days
Locations:
city: San Diego
country: United States
facility: Clinical Investigative Site 000015
state: California
city: San Francisco
country: United States
facility: Clinical Investigative Site 000012
state: California
city: Aurora
country: United States
facility: Clinical Investigative Site 00004
state: Colorado
city: Tampa
country: United States
facility: Clinical Investigative Site 000002
state: Florida
city: Lexington
country: United States
facility: Clinical Investigative Site 000005
state: Kentucky
city: Ann Arbor
country: United States
facility: Clinical Investigative Site 000009
state: Michigan
city: Livingston
country: United States
facility: Clinical Investigative Site 000010
state: New Jersey
city: Buffalo
country: United States
facility: Clinical Investigative Site 000011
state: New York
city: New York
country: United States
facility: Clinical Investigative Site 00006
state: New York
city: Cleveland
country: United States
facility: Clinical Investigative Site 00008
state: Ohio
city: Philadelphia
country: United States
facility: Clinical Investigative Site 00003
state: Pennsylvania
city: Dallas
country: United States
facility: Clinical Investigative Site 000013
state: Texas
city: Charlottesville
country: United States
facility: Clinical Investigative Site 00001
state: Virginia
Study officials:
affiliation: Veloxis Pharmaceuticals
name: William Polvino, MD
role: STUDY_DIRECTOR
References: