Expanded Access Study for Renal Transplant Patients With Envarsus XR ™

NCT ID: NCT02411604

Last Updated: 2016-01-20

Basic Information

• Recruitment Status: APPROVED_FOR_MARKETING
• Study Classification: EXPANDED_ACCESS

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.

Conditions

Renal Failure

Interventions

Tacrolimus

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

Intervention Type: DRUG

Other Intervention Names

Envarsus XR

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Veloxis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

Envarsus® 3007

Identifier Type: -

Identifier Source: org_study_id