Renal FailureNCT02411604
Expanded Access Study for Renal Transplant Patients With Envarsus XR ™
A study testing Tacrolimus in people with Renal Failure, run by Veloxis Pharmaceuticals.
Trial summary
Open label, multi-center, expanded access study for renal transplant patients with once daily Envarsus XR (Tacrolimus). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Failure
- What is being tested?
- Tacrolimus
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
Official title: 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).
Read the 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.
- Conditions
- Renal Failure
- Being tested
- Tacrolimus
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TacrolimusDrug
Also called Envarsus XR
Open label, multi-center, expanded access study for renal transplant patients with once daily Envarsus XR.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Veloxis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02411604
- Sponsor's protocol ID
- Envarsus® 3007
- Status last verified
- Dec 2015
- First submitted
- 2 Apr 2015
- Last updated
- 20 Jan 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access Study for Renal Transplant Patients With Envarsus XR™: Envarsus 3007
- ClinicalTrials.gov ID
- NCT02411604
- Acronym / sponsor ID
- Envarsus® 3007
- Conditions
- Renal Failure
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- Veloxis PharmaceuticalsIndustry (pharma, biotech, devices)
- First posted
- 8 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Eligible patients will fulfill all of the following criteria:
Key exclusion criteria (6 listed)
- Patients fulfilling any of the following criteria are NOT eligible for study inclusion:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TacrolimusAlso: Envarsus XROpen label, multi-center, expanded access study for renal transplant patients with once daily Envarsus XR. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Tacrolimus in people with Renal Failure, run by Veloxis Pharmaceuticals.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2016; AzTrials last refreshed its copy on 1 Nov 2026.