NCT02411604

Unknown

Expanded Access Study for Renal Transplant Patients With Env...

Veloxis Pharmaceuticals Source

Other study identifiers

Sponsor study identifier

Envarsus® 3007

Study Type

expanded_access

Reported enrollment (type unavailable)

N/A

Locations

0 countries

Sites

N/A

Timeline

Study Start

Not reported

Date not reported

Primary Completion

Not reported

Date not reported

Study Completion

Not reported

Date not reported

Brief Summary

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: unknown
Reported enrollment (type unavailable): Not reported
Study completion date: Not reported
Date not reported
Listed locations: 0 countries · 0 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
April 2, 2015
Actual (reported)
First Posted
April 8, 2015
Actual (reported)

Last Updated: January 20, 2016
Status Verified: December 2015
Last Update Submitted: January 19, 2016

Conditions

Renal Failure

Interventions

TacrolimusDrug

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

Also known as: Envarsus XR

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Eligible patients will fulfill all of the following criteria:
Patient age ≥18years old

Sponsors & Collaborators

Veloxis Pharmaceuticals
Industrylead

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Tacrolimus

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Design

Study Type: expanded access
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 2, 2015

First Posted

April 8, 2015

Last Updated

January 20, 2016

Record last verified: 2015-12

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT02411604
Data provider: ClinicalTrials.gov
Source updated: 2016-01-20
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:24:08 UTC

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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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Conditions

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Design

Study Record Dates

Source record

You may not qualify if: