Expanded Access Study for Renal Transplant Patients With Envarsus XR ™

NCT02411604 | Unknown

• 1 other identifier: Envarsus® 3007
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Renal Failure

Interventions

Tacrolimus DRUG

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

Also known as: Envarsus XR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

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

Sponsors & Collaborators

• Veloxis Pharmaceuticals: lead

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Tacrolimus

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic 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