Clincosm LogoSign in Get a demo

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

Sponsor
Veloxis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT01666951
Collaborator
(none)
36
Enrollment
13
Locations
2
Arms
5.9
Duration (Months)
2.8
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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 Start Date :
Nov 1, 2012
Actual Primary Completion Date :
Mar 1, 2013
Actual Study Completion Date :
May 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: LCP-Tacro

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

Drug: LCP-Tacro tablets
Tacrolimus
Other Names:
  • Prograf

    		•
    Active Comparator: Prograf

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

    Drug: Prograf
    Tacrolimus
    Other Names:
  • Prograf Capsules twice daily

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pharmacokinetics (AUC) of LCP-Tacro Compared to Prograf After Kidney Transplantation [1 days]

      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.

    2. Pharmacokinetics (AUC) of LCP-Tacro Compared to Prograf After Kidney Transplantation [14 days]

      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.

    3. Pharmacokinetics (AUC) of LCP-Tacro Compared to Prograf After Kidney Transplantation [28 days]

      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.

    4. Pharmacokinetics (Cmax and C24) of LCP-Tacro Compared to Prograf After Kidney Transplantation [1 days]

      The pharmacokinetic parameter (Cmax and C24) was evaluated on Day 1 in adult de novo kidney recipients.

    5. Pharmacokinetics (Cmax and C24) of LCP-Tacro Compared to Prograf After Kidney Transplantation [14 days]

      The pharmacokinetic parameter (Cmax and C24) was evaluated on Day 14 in adult de novo kidney recipients.

    6. Pharmacokinetics (Cmax and C24) of LCP-Tacro Compared to Prograf After Kidney Transplantation [28 days]

      The pharmacokinetic parameter (Cmax and C24) was evaluated on Day 28 in adult de novo kidney recipients.

    7. Pharmacokinetics (Tmax) of LCP-Tacro Compared to Prograf After Kidney Transplantation [1 days]

      The pharmacokinetic parameter (Tmax) was evaluated on Day 1 in adult de novo kidney recipients.

    8. Pharmacokinetics (Tmax) of LCP-Tacro Compared to Prograf After Kidney Transplantation [14 days]

      The pharmacokinetic parameter (Tmax) was evaluated on Day 14 in adult de novo kidney recipients.

    9. Pharmacokinetics (Tmax) of LCP-Tacro Compared to Prograf After Kidney Transplantation [28 days]

      The pharmacokinetic parameter (Tmax) was evaluated on Day 28 in adult de novo kidney recipients.

    10. Pharmacokinetics (Fluctuation) of LCP-Tacro Compared to Prograf After Kidney Transplantation [14 days]

      The pharmacokinetic parameter (Fluctuation) was evaluated on Day 14 in adult de novo kidney recipients.

    11. Pharmacokinetics (Fluctuation) of LCP-Tacro Compared to Prograf After Kidney Transplantation [28 days]

      The pharmacokinetic parameter (Fluctuation) was evaluated on Day 28 in adult de novo kidney recipients.

    Other Outcome Measures

    1. Daytime, Nighttime and Overnight Systolic Blood Pressure (SBP) on Day 14. [14 days]

      At selected sites, a 24-hour measurement of blood pressure will be performed to assess the variability (ei, "nighttime dipping") between the two Groups at Days 14.

    2. Daytime, Nighttime Overnight Systolic Blood Pressure (SBP) on Day 28. [28 days]

      At selected sites, a 24-hour measurement of blood pressure will be performed to assess the variability (ei, "nighttime dipping") between the two Groups at Day 28.

    3. Ratio of Nighttime to Daytime Systolic Blood Pressure (SBP) on Day 14. [14 days]

      At selected sites, a 24-hour measurement of blood pressure will be performed to assess the variability (ei, "nighttime dipping") between the two Groups at Days 14.

    4. Ratio of Nighttime to Daytime Systolic Blood Pressure (SBP) on Day 28. [28 days]

      At selected sites, a 24-hour measurement of blood pressure will be performed to assess the variability (ei, "nighttime dipping") between the two Groups at Days 28.

    5. Evaluation of the Short-term Efficacy of LCP-Tacro After the Start of Dosing. [30 days]

      The efficacy is measured by the number of treatment failures defined as all-cause mortality, Graft Failure, Biopsy Proven Acute Rejection (BPAR) and Lost to follow up.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clinical Investigative Site 000015 San Diego California United States 92123
    2 Clinical Investigative Site 000012 San Francisco California United States 94115
    3 Clinical Investigative Site 00004 Aurora Colorado United States 80045
    4 Clinical Investigative Site 000002 Tampa Florida United States 33606
    5 Clinical Investigative Site 000005 Lexington Kentucky United States 40536-0293
    6 Clinical Investigative Site 000009 Ann Arbor Michigan United States 48109
    7 Clinical Investigative Site 000010 Livingston New Jersey United States 07039
    8 Clinical Investigative Site 000011 Buffalo New York United States 14215
    9 Clinical Investigative Site 00006 New York New York United States 10016
    10 Clinical Investigative Site 00008 Cleveland Ohio United States 44095
    11 Clinical Investigative Site 00003 Philadelphia Pennsylvania United States 19104
    12 Clinical Investigative Site 000013 Dallas Texas United States 75246
    13 Clinical Investigative Site 00001 Charlottesville Virginia United States 22903

    Sponsors and Collaborators

    • Veloxis Pharmaceuticals

    Investigators

    • Study Director: William Polvino, MD, Veloxis Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Veloxis Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT01666951
    Other Study ID Numbers:
    • LCP-Tacro 2019
    First Posted:
    Aug 16, 2012
    Last Update Posted:
    Jul 7, 2015
    Last Verified:
    Jun 1, 2015
    Additional relevant MeSH terms:
    Renal Insufficiency
    Tacrolimus

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title LCP-Tacro Prograf
    Arm/Group Description LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK) LCP-Tacro tablets: Tacrolimus Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL) Prograf: Tacrolimus
    Period Title: Overall Study
    STARTED 18 18
    COMPLETED 17 17
    NOT COMPLETED 1 1

    Baseline Characteristics

    Arm/Group Title LCP-Tacro Prograf Total
    Arm/Group Description LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK) LCP-Tacro tablets: Tacrolimus Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL) Prograf: Tacrolimus Total of all reporting groups
    Overall Participants 17 17 34
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    16
    94.1%
    16
    94.1%
    32
    94.1%
    >=65 years
    1
    5.9%
    1
    5.9%
    2
    5.9%
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    51.5
    (13.92)
    46.4
    (11.49)
    49.0
    (12.84)
    Sex: Female, Male (Count of Participants)
    Female
    3
    17.6%
    8
    47.1%
    11
    32.4%
    Male
    14
    82.4%
    9
    52.9%
    23
    67.6%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    1
    5.9%
    4
    23.5%
    5
    14.7%
    Not Hispanic or Latino
    16
    94.1%
    13
    76.5%
    29
    85.3%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    1
    5.9%
    0
    0%
    1
    2.9%
    Asian
    1
    5.9%
    0
    0%
    1
    2.9%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    5
    29.4%
    5
    29.4%
    10
    29.4%
    White
    10
    58.8%
    12
    70.6%
    22
    64.7%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    Region of Enrollment (participants) [Number]
    United States
    17
    100%
    17
    100%
    34
    100%

    Outcome Measures

    1. Other Pre-specified Outcome
    Title Daytime, Nighttime and Overnight Systolic Blood Pressure (SBP) on Day 14.
    Description At selected sites, a 24-hour measurement of blood pressure will be performed to assess the variability (ei, "nighttime dipping") between the two Groups at Days 14.
    Time Frame 14 days

    Outcome Measure Data

    Analysis Population Description
    18 patients participated in the 24-hour blood pressure assessment, 8 in the LCP-Tacro arm and 10 on the Prograf arm.
    Arm/Group Title LCP-Tacro Prograf
    Arm/Group Description LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK) LCP-Tacro tablets: Tacrolimus Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL) Prograf: Tacrolimus
    Measure Participants 8 10
    Daytime SBP
    140.96
    (10,311)
    131.54
    (13.835)
    Nighttime SBP
    140.69
    (9.147)
    133.38
    (17.875)
    Overnight SBP
    140.80
    (10.347)
    132.54
    (18.127)
    2. Other Pre-specified Outcome
    Title Daytime, Nighttime Overnight Systolic Blood Pressure (SBP) on Day 28.
    Description At selected sites, a 24-hour measurement of blood pressure will be performed to assess the variability (ei, "nighttime dipping") between the two Groups at Day 28.
    Time Frame 28 days

    Outcome Measure Data

    Analysis Population Description
    18 patients participated in the 24-hour blood pressure assessment, 8 in the LCP-Tacro arm and 10 on the Prograf arm.
    Arm/Group Title LCP-Tacro Prograf
    Arm/Group Description LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK) LCP-Tacro tablets: Tacrolimus Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL) Prograf: Tacrolimus
    Measure Participants 8 10
    Daytime SBP
    139.05
    (14.722)
    130.84
    (15.754)
    Nighttime SBP
    137.18
    (13.283)
    129.09
    (16.447)
    Overnight SBP
    136.11
    (13.539)
    127.70
    (16.599)
    3. Primary Outcome
    Title Pharmacokinetics (AUC) of LCP-Tacro Compared to Prograf After Kidney Transplantation
    Description 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.
    Time Frame 1 days

    Outcome Measure Data

    Analysis Population Description
    The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.
    Arm/Group Title LCP-Tacro Prograf
    Arm/Group Description LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK) LCP-Tacro tablets: Tacrolimus Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL) Prograf: Tacrolimus
    Measure Participants 14 12
    Mean (Standard Deviation) [ng*hr/mL]
    382.72
    (233.84)
    147.82
    (85.31)
    4. Primary Outcome
    Title Pharmacokinetics (AUC) of LCP-Tacro Compared to Prograf After Kidney Transplantation
    Description 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.
    Time Frame 14 days

    Outcome Measure Data

    Analysis Population Description
    The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.
    Arm/Group Title LCP-Tacro Prograf
    Arm/Group Description LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK) LCP-Tacro tablets: Tacrolimus Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL) Prograf: Tacrolimus
    Measure Participants 14 12
    Mean (Standard Deviation) [ng*hr/mL]
    371.43
    (133.85)
    244.63
    (66.92)
    5. Primary Outcome
    Title Pharmacokinetics (AUC) of LCP-Tacro Compared to Prograf After Kidney Transplantation
    Description 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.
    Time Frame 28 days

    Outcome Measure Data

    Analysis Population Description
    The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.
    Arm/Group Title LCP-Tacro Prograf
    Arm/Group Description LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK) LCP-Tacro tablets: Tacrolimus Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL) Prograf: Tacrolimus
    Measure Participants 14 12
    Mean (Standard Deviation) [ng*hr/mL]
    357.39
    (146.64)
    205.79
    (36.25)
    6. Primary Outcome
    Title Pharmacokinetics (Cmax and C24) of LCP-Tacro Compared to Prograf After Kidney Transplantation
    Description The pharmacokinetic parameter (Cmax and C24) was evaluated on Day 1 in adult de novo kidney recipients.
    Time Frame 1 days

    Outcome Measure Data

    Analysis Population Description
    The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.
    Arm/Group Title LCP-Tacro Prograf
    Arm/Group Description LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK) LCP-Tacro tablets: Tacrolimus Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL) Prograf: Tacrolimus
    Measure Participants 14 12
    Cmax
    32.68
    (20.51)
    12.97
    (7.08)
    C24
    13.32
    (8.89)
    5.72
    (5.28)
    7. Primary Outcome
    Title Pharmacokinetics (Cmax and C24) of LCP-Tacro Compared to Prograf After Kidney Transplantation
    Description The pharmacokinetic parameter (Cmax and C24) was evaluated on Day 14 in adult de novo kidney recipients.
    Time Frame 14 days

    Outcome Measure Data

    Analysis Population Description
    The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.
    Arm/Group Title LCP-Tacro Prograf
    Arm/Group Description LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK) LCP-Tacro tablets: Tacrolimus Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL) Prograf: Tacrolimus
    Measure Participants 12 14
    Cmax
    30.08
    (14.27)
    18.98
    (6.59)
    C24
    9.11
    (2.86)
    7.54
    (2.50)
    8. Primary Outcome
    Title Pharmacokinetics (Cmax and C24) of LCP-Tacro Compared to Prograf After Kidney Transplantation
    Description The pharmacokinetic parameter (Cmax and C24) was evaluated on Day 28 in adult de novo kidney recipients.
    Time Frame 28 days

    Outcome Measure Data

    Analysis Population Description
    The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.
    Arm/Group Title LCP-Tacro Prograf
    Arm/Group Description LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK) LCP-Tacro tablets: Tacrolimus Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL) Prograf: Tacrolimus
    Measure Participants 12 14
    Cmax
    32.51
    (18.74)
    17.38
    (4.07)
    C24
    9.31
    (3.44)
    6.75
    (2.22)
    9. Primary Outcome
    Title Pharmacokinetics (Tmax) of LCP-Tacro Compared to Prograf After Kidney Transplantation
    Description The pharmacokinetic parameter (Tmax) was evaluated on Day 1 in adult de novo kidney recipients.
    Time Frame 1 days

    Outcome Measure Data

    Analysis Population Description
    The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.
    Arm/Group Title LCP-Tacro Prograf
    Arm/Group Description LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK) LCP-Tacro tablets: Tacrolimus Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL) Prograf: Tacrolimus
    Measure Participants 14 12
    Mean (Standard Deviation) [hour]
    11.26
    (7.49)
    7.39
    (6.37)
    10. Primary Outcome
    Title Pharmacokinetics (Tmax) of LCP-Tacro Compared to Prograf After Kidney Transplantation
    Description The pharmacokinetic parameter (Tmax) was evaluated on Day 14 in adult de novo kidney recipients.
    Time Frame 14 days

    Outcome Measure Data

    Analysis Population Description
    The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.
    Arm/Group Title LCP-Tacro Prograf
    Arm/Group Description LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK) LCP-Tacro tablets: Tacrolimus Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL) Prograf: Tacrolimus
    Measure Participants 14 12
    Mean (Standard Deviation) [hour]
    7.03
    (5.69)
    5.03
    (5.81)
    11. Primary Outcome
    Title Pharmacokinetics (Tmax) of LCP-Tacro Compared to Prograf After Kidney Transplantation
    Description The pharmacokinetic parameter (Tmax) was evaluated on Day 28 in adult de novo kidney recipients.
    Time Frame 28 days

    Outcome Measure Data

    Analysis Population Description
    The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.
    Arm/Group Title LCP-Tacro Prograf
    Arm/Group Description LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK) LCP-Tacro tablets: Tacrolimus Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL) Prograf: Tacrolimus
    Measure Participants 14 12
    Mean (Standard Deviation) [hour]
    5.69
    (4.11)
    7.69
    (6.87)
    12. Primary Outcome
    Title Pharmacokinetics (Fluctuation) of LCP-Tacro Compared to Prograf After Kidney Transplantation
    Description The pharmacokinetic parameter (Fluctuation) was evaluated on Day 14 in adult de novo kidney recipients.
    Time Frame 14 days

    Outcome Measure Data

    Analysis Population Description
    The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.
    Arm/Group Title LCP-Tacro Prograf
    Arm/Group Description LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK) LCP-Tacro tablets: Tacrolimus Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL) Prograf: Tacrolimus
    Measure Participants 14 12
    Mean (Standard Deviation) [Percentage of fluctuation]
    126.86
    (57.65)
    114.73
    (52.36)
    13. Primary Outcome
    Title Pharmacokinetics (Fluctuation) of LCP-Tacro Compared to Prograf After Kidney Transplantation
    Description The pharmacokinetic parameter (Fluctuation) was evaluated on Day 28 in adult de novo kidney recipients.
    Time Frame 28 days

    Outcome Measure Data

    Analysis Population Description
    The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.
    Arm/Group Title LCP-Tacro Prograf
    Arm/Group Description LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK) LCP-Tacro tablets: Tacrolimus Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL) Prograf: Tacrolimus
    Measure Participants 14 12
    Mean (Standard Deviation) [Percentage of fluctuation]
    144.78
    (84.63)
    131.4
    (75.96)
    14. Other Pre-specified Outcome
    Title Ratio of Nighttime to Daytime Systolic Blood Pressure (SBP) on Day 14.
    Description At selected sites, a 24-hour measurement of blood pressure will be performed to assess the variability (ei, "nighttime dipping") between the two Groups at Days 14.
    Time Frame 14 days

    Outcome Measure Data

    Analysis Population Description
    18 patients participated in the 24-hour blood pressure assessment, 8 in the LCP-Tacro arm and 10 on the Prograf arm.
    Arm/Group Title LCP-Tacro Prograf
    Arm/Group Description LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK) LCP-Tacro tablets: Tacrolimus Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL) Prograf: Tacrolimus
    Measure Participants 8 10
    Night:Day ratio SBP
    0.99
    (0.035)
    1.01
    (0.057)
    Overnight:Day Ratio SBP
    1.00
    (0.053)
    1.01
    (0.057)
    15. Other Pre-specified Outcome
    Title Ratio of Nighttime to Daytime Systolic Blood Pressure (SBP) on Day 28.
    Description At selected sites, a 24-hour measurement of blood pressure will be performed to assess the variability (ei, "nighttime dipping") between the two Groups at Days 28.
    Time Frame 28 days

    Outcome Measure Data

    Analysis Population Description
    18 patients participated in the 24-hour blood pressure assessment, 8 in the LCP-Tacro arm and 10 on the Prograf arm.
    Arm/Group Title LCP-Tacro Prograf
    Arm/Group Description LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK) LCP-Tacro tablets: Tacrolimus Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL) Prograf: Tacrolimus
    Measure Participants 8 10
    Night:Day ratio SBP
    0.99
    (0.035)
    0.98
    (0.067)
    Overnight:Day Ratio SBP
    0.99
    (0.064)
    0.98
    (0.067)
    16. Other Pre-specified Outcome
    Title Evaluation of the Short-term Efficacy of LCP-Tacro After the Start of Dosing.
    Description The efficacy is measured by the number of treatment failures defined as all-cause mortality, Graft Failure, Biopsy Proven Acute Rejection (BPAR) and Lost to follow up.
    Time Frame 30 days

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title LCP-Tacro Prograf
    Arm/Group Description LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK) LCP-Tacro tablets: Tacrolimus Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL) Prograf: Tacrolimus
    Measure Participants 18 16
    All-cause mortality
    0
    0%
    0
    0%
    Graft Failure
    0
    0%
    0
    0%
    BPAR
    2
    11.8%
    0
    0%
    Lost to follow up
    0
    0%
    0
    0%

    Adverse Events

    Time Frame Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
    Adverse Event Reporting Description
    Arm/Group Title LCP-Tacro Prograf
    Arm/Group Description LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK) LCP-Tacro tablets: Tacrolimus Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL) Prograf: Tacrolimus
    All Cause Mortality
    LCP-Tacro Prograf
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    LCP-Tacro Prograf
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 5/17 (29.4%) 5/17 (29.4%)
    Cardiac disorders
    Angina Pectoris 1/17 (5.9%) 1 0/17 (0%) 0
    Atrial Fibrilation 1/17 (5.9%) 1 0/17 (0%) 0
    Ventricular Tachycardia 0/17 (0%) 0 1/17 (5.9%) 1
    Gastrointestinal disorders
    Nausea 1/17 (5.9%) 1 1/17 (5.9%) 1
    Vomiting 1/17 (5.9%) 1 1/17 (5.9%) 1
    Immune system disorders
    Kidney transplant rejection 2/17 (11.8%) 2 0/17 (0%) 0
    Infections and infestations
    Pelvic Abscess 1/17 (5.9%) 1 0/17 (0%) 0
    Sepsis 0/17 (0%) 0 1/17 (5.9%) 1
    Wound infection 0/17 (0%) 0 1/17 (5.9%) 1
    Injury, poisoning and procedural complications
    Toxicity to various agents 0/17 (0%) 0 1/17 (5.9%) 1
    Investigations
    Blood creatinine increased 0/17 (0%) 0 1/17 (5.9%) 1
    Nervous system disorders
    Syncope 0/17 (0%) 0 1/17 (5.9%) 1
    Renal and urinary disorders
    Renal INjury 1/17 (5.9%) 1 0/17 (0%) 0
    Vascular disorders
    Hypertension 0/17 (0%) 0 1/17 (5.9%) 1
    Other (Not Including Serious) Adverse Events
    LCP-Tacro Prograf
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 17/17 (100%) 17/17 (100%)
    Blood and lymphatic system disorders
    Anaemia 1/17 (5.9%) 1 0/17 (0%) 0
    Leukopenia 1/17 (5.9%) 1 2/17 (11.8%) 2
    Cardiac disorders
    Angina pectoris 1/17 (5.9%) 1 0/17 (0%) 0
    Atrial fibrilation 1/17 (5.9%) 2 0/17 (0%) 0
    Palpitations 1/17 (5.9%) 1 0/17 (0%) 0
    Sinus Tachycardia 1/17 (5.9%) 1 0/17 (0%) 0
    Tachycardia 1/17 (5.9%) 1 0/17 (0%) 0
    Ventricular tachycardia 0/17 (0%) 0 1/17 (5.9%) 1
    Endocrine disorders
    Hyperparathyroidism 0/17 (0%) 0 1/17 (5.9%) 1
    Eye disorders
    Uveitis 1/17 (5.9%) 1 0/17 (0%) 0
    Gastrointestinal disorders
    Abdominal Distension 1/17 (5.9%) 1 1/17 (5.9%) 1
    Abdominal pain 2/17 (11.8%) 2 1/17 (5.9%) 1
    Abdominal pain lower 2/17 (11.8%) 2 0/17 (0%) 0
    Constipation 6/17 (35.3%) 6 7/17 (41.2%) 7
    Diarrhoea 4/17 (23.5%) 4 2/17 (11.8%) 2
    Dyspepsia 0/17 (0%) 0 1/17 (5.9%) 1
    Flatulence 3/17 (17.6%) 3 1/17 (5.9%) 1
    Gastrooesophageal reflux disease 2/17 (11.8%) 2 1/17 (5.9%) 1
    Haemorrhoids 1/17 (5.9%) 1 1/17 (5.9%) 1
    Nausea 2/17 (11.8%) 2 3/17 (17.6%) 4
    Vomiting 1/17 (5.9%) 1 2/17 (11.8%) 2
    General disorders
    Catheter site realted reaction 1/17 (5.9%) 1 0/17 (0%) 0
    Exercise tolerance decreased 1/17 (5.9%) 1 0/17 (0%) 0
    Fatigue 2/17 (11.8%) 2 0/17 (0%) 0
    Hyperthermia 1/17 (5.9%) 1 0/17 (0%) 0
    Oedema 2/17 (11.8%) 2 0/17 (0%) 0
    Oedema peripheral 4/17 (23.5%) 4 0/17 (0%) 0
    Pyrexia 0/17 (0%) 0 1/17 (5.9%) 1
    Immune system disorders
    Kidney transplant rejection 2/17 (11.8%) 2 0/17 (0%) 0
    Infections and infestations
    Nasopharyngitis 1/17 (5.9%) 1 0/17 (0%) 0
    Oral Candidiasis 1/17 (5.9%) 1 0/17 (0%) 0
    Pelvic abscess 1/17 (5.9%) 1 0/17 (0%) 0
    Sepsis 0/17 (0%) 0 1/17 (5.9%) 1
    Urinary tract infection 0/17 (0%) 0 1/17 (5.9%) 2
    Vulvovaginal myotic infection 0/17 (0%) 0 1/17 (5.9%) 1
    Wound infection 0/17 (0%) 0 1/17 (5.9%) 1
    Injury, poisoning and procedural complications
    Incision site erythema 1/17 (5.9%) 1 0/17 (0%) 0
    Incision site haemorrhage 0/17 (0%) 0 1/17 (5.9%) 1
    Incision site pain 1/17 (5.9%) 1 1/17 (5.9%) 1
    Laceration 0/17 (0%) 0 1/17 (5.9%) 1
    Muscle strain 0/17 (0%) 0 1/17 (5.9%) 1
    Procedural pain 1/17 (5.9%) 2 2/17 (11.8%) 2
    Seroma 0/17 (0%) 0 1/17 (5.9%) 1
    Toxicity to various agents 1/17 (5.9%) 1 1/17 (5.9%) 1
    Investigations
    Blood creatinine increased 3/17 (17.6%) 3 3/17 (17.6%) 3
    Blood pressure increased 0/17 (0%) 0 1/17 (5.9%) 1
    Drug level increased 1/17 (5.9%) 1 1/17 (5.9%) 1
    Oxygen saturation decreased 0/17 (0%) 0 1/17 (5.9%) 1
    Polyomavirus test positive 1/17 (5.9%) 2 0/17 (0%) 0
    Vitamin D decreased 1/17 (5.9%) 1 0/17 (0%) 0
    Weight decreased 1/17 (5.9%) 1 1/17 (5.9%) 1
    Metabolism and nutrition disorders
    Dehydration 1/17 (5.9%) 1 2/17 (11.8%) 2
    Diabetes mellitus 2/17 (11.8%) 2 0/17 (0%) 0
    Diabetes mellitus inadequate control 1/17 (5.9%) 1 0/17 (0%) 0
    Electrolyte imbalance 0/17 (0%) 0 1/17 (5.9%) 1
    Fluid overload 1/17 (5.9%) 1 0/17 (0%) 0
    Hypercalcaemia 0/17 (0%) 0 1/17 (5.9%) 1
    Hyperglycaemia 1/17 (5.9%) 1 2/17 (11.8%) 2
    Hyperkalaemia 3/17 (17.6%) 4 0/17 (0%) 0
    Hyperlipidaemia 1/17 (5.9%) 1 1/17 (5.9%) 1
    Hypocalcaemia 1/17 (5.9%) 1 2/17 (11.8%) 2
    Hypokalaemia 0/17 (0%) 0 1/17 (5.9%) 1
    Hypomagnesaemia 3/17 (17.6%) 3 1/17 (5.9%) 1
    Hypophosphataemia 2/17 (11.8%) 2 2/17 (11.8%) 2
    Hypovitaminosis 0/17 (0%) 0 1/17 (5.9%) 1
    Metabolic acidosis 1/17 (5.9%) 1 1/17 (5.9%) 1
    Vimatin D deficiency 1/17 (5.9%) 1 2/17 (11.8%) 2
    Musculoskeletal and connective tissue disorders
    Arthralgia 1/17 (5.9%) 1 0/17 (0%) 0
    Muscle spasms 1/17 (5.9%) 1 1/17 (5.9%) 1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lung neoplasm 0/17 (0%) 0 1/17 (5.9%) 1
    Thyroid neoplasm 0/17 (0%) 0 1/17 (5.9%) 1
    Nervous system disorders
    Headache 1/17 (5.9%) 1 1/17 (5.9%) 1
    Neuropathy peripheral 0/17 (0%) 0 1/17 (5.9%) 1
    Paraesthesia 1/17 (5.9%) 1 0/17 (0%) 0
    Syncope 0/17 (0%) 0 1/17 (5.9%) 1
    Tremor 4/17 (23.5%) 4 2/17 (11.8%) 2
    Perinephric effusion 0/17 (0%) 0 1/17 (5.9%) 1
    Psychiatric disorders
    Anxiety 2/17 (11.8%) 2 1/17 (5.9%) 1
    Insomnia 2/17 (11.8%) 2 1/17 (5.9%) 1
    Renal and urinary disorders
    Haematuria 2/17 (11.8%) 2 1/17 (5.9%) 1
    Hydronephrosis 0/17 (0%) 0 1/17 (5.9%) 1
    Pollakiuria 1/17 (5.9%) 1 0/17 (0%) 0
    Pyelocaliectasis 0/17 (0%) 0 1/17 (5.9%) 1
    Renal injury 1/17 (5.9%) 1 0/17 (0%) 0
    Urinary retention 0/17 (0%) 0 1/17 (5.9%) 1
    Reproductive system and breast disorders
    Penile pain 1/17 (5.9%) 1 0/17 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Cough 0/17 (0%) 0 2/17 (11.8%) 2
    Dyspnoea 1/17 (5.9%) 1 0/17 (0%) 0
    Dyspnoea exertional 1/17 (5.9%) 1 0/17 (0%) 0
    Oropharyngeal pain 1/17 (5.9%) 1 0/17 (0%) 0
    Throat irritation 1/17 (5.9%) 1 0/17 (0%) 0
    Upper-airway cough syndrome 1/17 (5.9%) 1 0/17 (0%) 0
    Skin and subcutaneous tissue disorders
    Pruritus 0/17 (0%) 0 2/17 (11.8%) 2
    Rash 1/17 (5.9%) 1 2/17 (11.8%) 2
    Vascular disorders
    Flushing 1/17 (5.9%) 1 0/17 (0%) 0
    Hypertension 2/17 (11.8%) 3 4/17 (23.5%) 4
    Hypotension 1/17 (5.9%) 2 0/17 (0%) 0

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    Results Point of Contact

    Name/Title Christina Sylvest
    Organization Veloxis Pharmaceuticals
    Phone +4520553877
    Email csy@veloxis.com
    Responsible Party:
    Veloxis Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT01666951
    Other Study ID Numbers:
    • LCP-Tacro 2019
    First Posted:
    Aug 16, 2012
    Last Update Posted:
    Jul 7, 2015
    Last Verified:
    Jun 1, 2015