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Completed

NCT Number: NCT01962922

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

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.

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Key information

Conditions

Renal Failure Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Illinois, Chicago, Chicago, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LCP-Tacro

Drug

once-daily extended release tablet

Other names: Envarsus XR

Tacrolimus -IR

Drug

twice daily capsules

Other names: Prograf, Generic Tacrolimus

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Veloxis Pharmaceuticals

Industry

Registry information

Official study 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.

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Oct 14, 2013
Registry last updated
Jun 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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