A Phase 2 Double-Blind, Double-dummy, Multicenter, Prospective, Randomized Study of the Pharmacokinetics of LCP-Tacro Tablets, Once-Daily, Compared to Prograf Capsules, Twice-daily, for the Prevention of Acute Allograft Rejection in De Novo Adult Kidney Transplant Recipients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Veloxis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01666951
First received: August 14, 2012
Last updated: September 9, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Renal Failure
Drug: LCP-Tacro tablets
Drug: Prograf
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2 Double-Blind, Double-dummy, Multicenter, Prospective, Randomized Study of the Pharmacokinetics of LCP-Tacro Tablets, Once-Daily, Compared to Prograf Capsules, Twice-daily, for the Prevention of Acute Allograft Rejection in De Novo Adult Kidney Transplant Recipients

Resource links provided by NLM:


Further study details as provided by Veloxis Pharmaceuticals:

Primary Outcome Measures:
  • 24 hour Pharmacokinetic profile of LCP-Tacro vs Prograf on Days 1, 14 and 28 in adult de novo kidney recipients [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison of 24-hour pharmacokinetic profiles, safety, pharmacodynamics (ambulatory blood pressure monitoring) and efficacy (death, graft failure and centrally read biopsy-proven acute rejection) of LCP-Tacro vs Prograf in 28 days. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Enrollment: 36
Study Start Date: November 2012
Study Completion Date: May 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LCP-Tacro
LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)
Drug: LCP-Tacro tablets
Tacrolimus
Other Name: Prograf
Active Comparator: Prograf
Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)
Drug: Prograf
Tacrolimus
Other Name: Prograf Capsules twice daily

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must be able to give written consent.
  • Male and female subjects between the ages of 18 and 70 years, inclusive.
  • Subjects must be receiving primary or secondary renal allograft from a deceased donor or non-HLA identical living donor.
  • Women of childbearing potential (WOCBP) must have a negative pregnancy test (serum or urine pregnancy test with a sensitivity of a least 25 mIU/ml) within 1 week prior to randomization or in accordance with local regulations, whichever is of shorter duration. All subjects must agree to follow the contraceptive guidelines as detained in section 8.2.4.
  • Subjects must have negative cross-match test and be ABO-compatible.
  • Subjects must be able to swallow tablets and capsules

Exclusion Criteria:

  • Subjects who are recipients of any previous non-renal concurrent transplant (solid organ or bone marrow)
  • Subjects who have panel reactive antibody > 50%
  • Subjects with any condition that may affect study drug absorption (eg, gastrectomy or clinically significant diabetic gastroenteropathy, inflammatory bowel disease, or gastric bypass)
  • Subjects with body mass index (BMI) , 18 kg/m2 or > 45 kg/m2, calculated using the formula of BMI = mass/(height2)
  • Subjects with history of alcohol abuse with less than 6 months of sobriety
  • Subjects with history of recreational drug abuse with less than 6 months of documented abstinence
  • Subjects with screening 12-lead ECG demonstrating clinically significant abnormalities (including QTc prolongation)
  • Subjects who are 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 of contraception and follow the contraception guidelines in 8.2.4
  • Subjects with an oral temperature (prior to study drug dosing) of 38C (100.4F) or higher
  • Subjects with clinically significant active infections (eg, those requiring hospitalization, or as judged by the Investigator)
  • Subjects with known hereditary immunodeficiency
  • Subjects with 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 carinoma in situ
  • Subjects who 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
  • Subjects with any psychiatric or medical condition (cardiac, pulmonary, central nervous system, gastrointestinal, endocrine/metabolic, etc) 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
  • Subjects with clinically symptomatic congestive heart failure or documented rejection fraction of less than 45%
  • Subjects with significant chronic obstructive pulmonary disease, pulmonary restrictive disease or significant pulmonary hypertension
  • Subjects currently enrolled in another investigational drug or device study, who are less than 30 days since discontinuing another investigational drug or device study, or who are currently receiving other investigational treatment
  • Subjects with laboratory variables that are abnormal (outside laboratory reference range) and clinically significant as judged by the Investigator
  • Subjects with 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). Negative results for these serological tests much be documented within 12 months prior to randomization
  • Subjects who have had primary focal segmental glomerulosclerosis
  • Donor parameters must not include any of the following known conditions:

Positive serological test result for HIV-1, HBV or HCV History of malignant disease (current or historical) Cold ischemia time > 30 hours Non-heart-beating donor

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01666951

Locations
United States, California
Clinical Investigative Site 000015
San Diego, California, United States, 92123
Clinical Investigative Site 000012
San Francisco, California, United States, 94115
United States, Colorado
Clinical Investigative Site 00004
Aurora, Colorado, United States, 80045
United States, Florida
Clinical Investigative Site 000002
Tampa, Florida, United States, 33606
United States, Kentucky
Clinical Investigative Site 000005
Lexington, Kentucky, United States, 40536-0293
United States, Michigan
Clinical Investigative Site 000009
Ann Arbor, Michigan, United States, 48109
United States, New Jersey
Clinical Investigative Site 000010
Livingston, New Jersey, United States, 07039
United States, New York
Clinical Investigative Site 000011
Buffalo, New York, United States, 14215
Clinical Investigative Site 00006
New York, New York, United States, 10016
United States, Ohio
Clinical Investigative Site 00008
Cleveland, Ohio, United States, 44095
United States, Pennsylvania
Clinical Investigative Site 00003
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Clinical Investigative Site 000013
Dallas, Texas, United States, 75246
United States, Virginia
Clinical Investigative Site 00001
Charlottesville, Virginia, United States, 22903
Sponsors and Collaborators
Veloxis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Veloxis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01666951     History of Changes
Other Study ID Numbers: LCP-Tacro 2019
Study First Received: August 14, 2012
Last Updated: September 9, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014