Multicenter, Prospective, Rand, PK Study of LCP-Tacro™ Compared to Prograf® Capsules in De Novo Adult Kidney Transplant
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
1 other identifier
interventional
36
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Nov 2012
Shorter than P25 for phase_2
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 14, 2012
CompletedFirst Posted
Study publicly available on registry
August 16, 2012
CompletedStudy Start
First participant enrolled
November 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedResults Posted
Study results publicly available
July 7, 2015
CompletedJuly 7, 2015
June 1, 2015
4 months
August 14, 2012
May 19, 2015
June 30, 2015
Conditions
Outcome Measures
Primary Outcomes (11)
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
Other Outcomes (5)
Daytime, Nighttime and Overnight Systolic Blood Pressure (SBP) on Day 14.
14 days
Daytime, Nighttime Overnight Systolic Blood Pressure (SBP) on Day 28.
28 days
Ratio of Nighttime to Daytime Systolic Blood Pressure (SBP) on Day 14.
14 days
- +2 more other outcomes
Study Arms (2)
LCP-Tacro
EXPERIMENTALLCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)
Prograf
ACTIVE COMPARATORPrograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)
Interventions
Eligibility Criteria
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%
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Clinical Investigative Site 000015
San Diego, California, 92123, United States
Clinical Investigative Site 000012
San Francisco, California, 94115, United States
Clinical Investigative Site 00004
Aurora, Colorado, 80045, United States
Clinical Investigative Site 000002
Tampa, Florida, 33606, United States
Clinical Investigative Site 000005
Lexington, Kentucky, 40536-0293, United States
Clinical Investigative Site 000009
Ann Arbor, Michigan, 48109, United States
Clinical Investigative Site 000010
Livingston, New Jersey, 07039, United States
Clinical Investigative Site 000011
Buffalo, New York, 14215, United States
Clinical Investigative Site 00006
New York, New York, 10016, United States
Clinical Investigative Site 00008
Cleveland, Ohio, 44095, United States
Clinical Investigative Site 00003
Philadelphia, Pennsylvania, 19104, United States
Clinical Investigative Site 000013
Dallas, Texas, 75246, United States
Clinical Investigative Site 00001
Charlottesville, Virginia, 22903, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Christina Sylvest
- Organization
- Veloxis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
William Polvino, MD
Veloxis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 14, 2012
First Posted
August 16, 2012
Study Start
November 1, 2012
Primary Completion
March 1, 2013
Study Completion
May 1, 2013
Last Updated
July 7, 2015
Results First Posted
July 7, 2015
Record last verified: 2015-06