Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2026-01-01 @ 11:48 AM
Study NCT ID:
NCT02411604
Status:
APPROVED_FOR_MARKETING
Last Update Posted:
2016-01-20
First Post:
2015-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Expanded Access Study for Renal Transplant Patients With Envarsus XR ™
Sponsor:
Veloxis Pharmaceuticals
Organization:
Study Overview
Official Title:
Expanded Access Study for Renal Transplant Patients With Envarsus XR™: Envarsus 3007
Status:
APPROVED_FOR_MARKETING
Status Verified Date:
2015-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: