Expanded Access Study for Renal Transplant Patients With Envarsus XR ™

January 19, 2016 updated by: Veloxis Pharmaceuticals

Expanded Access Study for Renal Transplant Patients With Envarsus XR™: Envarsus 3007

Open label, multi-center, expanded access study for renal transplant patients with once daily Envarsus XR (Tacrolimus).

Study Overview

Status

Approved for marketing

Conditions

Intervention / Treatment

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.

Study Type

Expanded Access

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Veloxis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

April 2, 2015

First Submitted That Met QC Criteria

April 7, 2015

First Posted (Estimate)

April 8, 2015

Study Record Updates

Last Update Posted (Estimate)

January 20, 2016

Last Update Submitted That Met QC Criteria

January 19, 2016

Last Verified

December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Envarsus® 3007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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