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Expanded Access Study for Renal Transplant Patients With Envarsus XR ™

Primary Purpose

Renal Failure

Status
Approved for marketing
Phase
Locations
Study Type
Expanded Access
Intervention
Tacrolimus
Sponsored by
Veloxis Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Renal Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

Inclusion Criteria:

  • Eligible patients will fulfill all of the following criteria:

    1. Patient age ≥18years old
    2. Willing to give written informed consent and is able to speak, write and understand English
    3. Patient understands potential risks or benefits with treatment of Envarsus XR
    4. Patients who have received a primary or secondary kidney transplant
    5. Patient who have received prior treatment with Envarsus XR (LCP-Tacro) and who are not currently participating in an Envarsus/LCP-Tacro study OR
    6. The treating Investigator has identified the patient as having a medical necessity for switching from their current tacrolimus treatment to Envarsus XR: Investigator is aware the medical necessity for switching is not related to the inability to purchase available tacrolimus.

Exclusion Criteria:

  • Patients fulfilling any of the following criteria are NOT eligible for study inclusion:

    1. Recipients of organ transplants other than kidney
    2. Pregnant or nursing (lactating) women, or planning to become pregnant, where pregnancy is defined as a state of female after conception and until the termination of gestation, confirmed by a positive hCG serum or urine laboratory test.
    3. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant who are unwilling to use a defined SOC method of contraception, UNLESS they are
  • Women whose career, lifestyle, or sexual orientation preclude intercourse with a male partner
  • Women whose partners have been sterilized by vasectomy or other medically approved means

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    April 2, 2015
    Last Updated
    January 19, 2016
    Sponsor
    Veloxis Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02411604
    Brief Title
    Expanded Access Study for Renal Transplant Patients With Envarsus XR ™
    Official Title
    Expanded Access Study for Renal Transplant Patients With Envarsus XR™: Envarsus 3007
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    December 2015
    Overall Recruitment Status
    Approved for marketing
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Veloxis Pharmaceuticals

    4. Oversight

    5. Study Description

    Brief Summary
    Open label, multi-center, expanded access study for renal transplant patients with once daily Envarsus XR (Tacrolimus).
    Detailed Description
    The study is designed to facilitate expanded access of Envarsus XR treatment to renal transplant patients. Patients are identified by the site investigator as a patient who has experienced favorable outcomes while in an Envarsus XR (LCP-Tacro) clinical study and/or the site investigator has identified a renal transplant patient with a medical need for an alternative tacrolimus treatment versus the patient's current tacrolimus treatment.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Renal Failure

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Tacrolimus
    Other Intervention Name(s)
    Envarsus XR
    Intervention Description
    Open label, multi-center, expanded access study for renal transplant patients with once daily Envarsus XR.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Eligibility Criteria
    Inclusion Criteria: Eligible patients will fulfill all of the following criteria: Patient age ≥18years old Willing to give written informed consent and is able to speak, write and understand English Patient understands potential risks or benefits with treatment of Envarsus XR Patients who have received a primary or secondary kidney transplant Patient who have received prior treatment with Envarsus XR (LCP-Tacro) and who are not currently participating in an Envarsus/LCP-Tacro study OR The treating Investigator has identified the patient as having a medical necessity for switching from their current tacrolimus treatment to Envarsus XR: Investigator is aware the medical necessity for switching is not related to the inability to purchase available tacrolimus. Exclusion Criteria: Patients fulfilling any of the following criteria are NOT eligible for study inclusion: Recipients of organ transplants other than kidney Pregnant or nursing (lactating) women, or planning to become pregnant, where pregnancy is defined as a state of female after conception and until the termination of gestation, confirmed by a positive hCG serum or urine laboratory test. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant who are unwilling to use a defined SOC method of contraception, UNLESS they are Women whose career, lifestyle, or sexual orientation preclude intercourse with a male partner Women whose partners have been sterilized by vasectomy or other medically approved means

    12. IPD Sharing Statement

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    Expanded Access Study for Renal Transplant Patients With Envarsus XR ™

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