Expanded Access Study for Renal Transplant Patients With Envarsus XR ™

Renal Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Approved for marketing

Administrative data

• NCT number: NCT02411604
• Other study ID #: Envarsus® 3007
• Status: Approved for marketing
• Phase: N/A
• First received: April 2, 2015
• Last updated: January 19, 2016

Study information

• Verified date: December 2015
• Source: Veloxis Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Expanded Access

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Approved for marketing
• Enrollment: 0
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

N/A

Related Conditions & MeSH terms

• Renal Failure

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Veloxis Pharmaceuticals