Trials / Approved For Marketing

Approved For MarketingNCT02411604

Expanded Access Study for Renal Transplant Patients With Envarsus XR ™

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

Status: Approved For Marketing
Phase: —
Study type: Expanded Access
Enrollment: —

Sponsor: Veloxis Pharmaceuticals · Industry
Sex: All
Age: 18 Years
Healthy volunteers: —

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

Type	Name	Description
DRUG	Tacrolimus	Open label, multi-center, expanded access study for renal transplant patients with once daily Envarsus XR.

Timeline

First posted: 2015-04-08
Last updated: 2016-01-20

Source: ClinicalTrials.gov record NCT02411604. Inclusion in this directory is not an endorsement.