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Crossover Study to Compare PK of Once Daily LCP-Tacro Tablets to Generic Tacrolimus Capsules Twice Daily.

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ClinicalTrials.gov Identifier: NCT01962922
Recruitment Status : Completed
First Posted : October 14, 2013
Results First Posted : August 15, 2016
Last Update Posted : June 6, 2018
Sponsor:
Information provided by (Responsible Party):
Veloxis Pharmaceuticals

Brief Summary:
Open label, prospective, single-center, randomized, two sequence, three period crossover study to compare the steady state pharmacokinetics of LCP-Tacro tables to generic tacrolimus capsules administered twice daily in stable African-American renal transplant patients.

Condition or disease Intervention/treatment Phase
Renal Failure Drug: LCP-Tacro Drug: Tacrolimus -IR Phase 3

Detailed Description:

This is open label, prospective, single-center, randomized, two sequence, three period crossover study to compare the steady state pharmacokinetics of once daily dosing of LCP-Tacro tablets to tacrolimus capsules administered twice daily in stable African American kidney transplant patients.

Approximately 72 male and female African American renal transplant patients on table immunosuppression regimens will be randomly assigned in a 1:1 ratio to one of two sequences:

Sequence 1: (n=36) 18 patients requiring less than 0.15 mg/kg/day and 18 patients requiring equal to or greater than 0.15 mg/kg/day. Patients will continue on generic tacrolimus capsules on days 1-7 (24 hours PK profile on day 7) then patients are switched to LCP-Tacro tablets (at 15% lower dose of twice daily generic tacrolimus) on day 8.

Sequence 2: (n=36) 18 patients requiring less than 0.15 mg/kg/day and 18 patients requiring equal to or greater than 0.15 mg/kg/day. Patients will receive LCP-Tacro tablets (at 15% lower dose than generic tacrolimus twice daily formulation) on days 1-7 (24 hour PK profile on day 7) patients are switched back to twice daily generic tacrolimus treatment beginning on day 8.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective, Rand, Open-label, Single-center, 2 Sequence, 3 Period Crossover Study to Compare the Steady State PK of Once-Daily-Extended Release LCP-Tacro to Generic Tacrolimus Capsules Twice Daily in Stable A A Renal Transplant pt.
Study Start Date : November 2013
Actual Primary Completion Date : July 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus

Arm Intervention/treatment
Active Comparator: LCP-Tacro
Envarsus XR
Drug: LCP-Tacro
once-daily extended release tablet
Other Name: Envarsus XR

Active Comparator: Tacrolimus - IR
Tacrolimus
Drug: Tacrolimus -IR
twice daily capsules
Other Names:
  • Prograf
  • Generic Tacrolimus




Primary Outcome Measures :
  1. Evaluation of AUC(0-24) for Envarsus XR and IR-Tac [ Time Frame: Day 7 ]

    Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate AUC(0-24). Arithmetic mean and standard deviation is given below.

    Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours.


  2. Evaluation of C(Max) for Envarsus XR and IR-Tac [ Time Frame: Day 7 ]

    Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate C(max). Arithmetic mean and standard deviation is given below.

    Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours.


  3. Evaluation of C(Min) for Envarsus XR and IR-Tac [ Time Frame: Day 7 ]

    Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate AUC(0-24). Arithmetic mean and standard deviation is given below.

    Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours.


  4. Evaluation of AUC(0-24) for Envarsus XR and IR-Tac [ Time Frame: Day 14 ]

    Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate AUC(0-24). Arithmetic mean and standard deviation is given below.

    Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours.


  5. Evaluation of C(Max) for Envarsus XR and IR-Tac [ Time Frame: Day 14 ]

    Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate C(max). Arithmetic mean and standard deviation is given below.

    Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours.


  6. Evaluation of C(Min) for Envarsus XR and IR-Tac [ Time Frame: Day 14 ]

    Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate AUC(0-24). Arithmetic mean and standard deviation is given below.

    Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours


  7. Evaluation of AUC(0-24) for Envarsus XR and IR-Tac [ Time Frame: Day 21 ]

    Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate AUC(0-24). Arithmetic mean and standard deviation is given below.

    Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours.


  8. Evaluation of C(Max) for Envarsus XR and IR-Tac [ Time Frame: Day 21 ]

    Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate C(max). Arithmetic mean and standard deviation is given below.

    Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours.


  9. Evaluation of C(Min) for Envarsus XR and IR-Tac [ Time Frame: Day 21 ]

    Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate AUC(0-24). Arithmetic mean and standard deviation is given below.

    Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours.




Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Age ≥18-80 old, male or female
  • African Americans
  • Willing to give written informed consent and to comply with study visits and restrictions, including being able to speak, write and understand English
  • Pt who have received a primary or secondary transplant
  • Pt least 6 (six) mth post-transplant and on a stable dose of tacrolimus
  • BMI ≥19
  • Pt who are sero-positive for Hepatitis B or C positive may also be enrolled
  • Pt maintained on concurrent immunosuppression with stable doses during screening
  • Pt on a proton PPI remain on the same PPI formulation and dose during the PK portion of the study.
  • During PK phase Only: Pt taking any medication that could interfere with tacrolimus blood levels, including prescription and over-the-counter medications, herbal or food supplements (including grapefruit, and pomegranate products), or medications must continue the same dose and are willing to continue the same dose/routine
  • During PK phase Only: the patient is not scheduled to begin any new medication that could interfere with tacrolimus blood levels, including prescription and over-the-counter medications, herbal or food

Exclusion Criteria:

  • Evidence of acute rejection episode within the past three months
  • Pt not Africa-American
  • Recipients of organ transplants other than kidney
  • Known to be HIV positive at transplant
  • Pt with recurrent focal segmental glomerulosclerosis (FSGS)
  • Pt with any severe medical condition (including infection) requiring acute or chronic treatment
  • Pt with a positive DSA
  • Pt with a positive BK virus results
  • GFR < 25 ml/min measured by MDRD4 as SOC within last 30 days
  • Patients with AST, ALT, total bilirubin > 2.5 x ULN or evidence of severe liver disease
  • Pt with WBC < to 2000/mm3 or ANC < to 1500 mm3 with PLT < 75,000/mm3 or HGB < 8 g/dl
  • Pt with mental or physical conditions or known non-adherence
  • Presence of intractable immunosuppressant complications of side effects resulting in dose adjustment of tacrolimus
  • Exposed to investigational therapy within 30 days prior to enrollment
  • No anticipated changes in the immunosuppressive regimen, other than those specified by the study protocol
  • Pt with severe diabetic gastroparesis or other severe GI disturbances
  • Pt who have underwent gastric banding or gastric bypass at any time pre or post-transplant
  • Pregnant or nursing (lactating) women, or planning to become pregnant
  • Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant who are unwilling to use a defined SOC of method

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01962922


Locations
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United States, Illinois
University of Illinois, Chicago
Chicago, Illinois, United States, 60612
United States, Missouri
Washingto University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Veloxis Pharmaceuticals
Investigators
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Study Director: Leslie Callahan, RN Veloxis Pharmaceuticals
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Veloxis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01962922    
Other Study ID Numbers: LCP-Tacro 3004
First Posted: October 14, 2013    Key Record Dates
Results First Posted: August 15, 2016
Last Update Posted: June 6, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Diseases
Urologic Diseases
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action