Envarsus XR in Lung Transplant

PHASE2CompletedINTERVENTIONAL
Enrollment

41

Participants

Timeline

Start Date

October 23, 2020

Primary Completion Date

November 30, 2022

Study Completion Date

November 30, 2022

Conditions
Lung Transplant
Interventions
DRUG

Extended-Release Tacrolimus

Envarsus XR is an FDA-approved drug for the prophylaxis of organ rejection in de novo kidney transplant patients or in kidney transplant patients converted from IR tacrolimus when used with other immunosuppressants. Envarsus XR is a novel extended-release formulation of tacrolimus created using MeltDose technology. Envarsus XR is available in tablet form. It is available in 0.75, 1, and 4 mg tablets.

DRUG

Immediate-Release Tacrolimus

Historical cohort of 20 subjects who will be maintained on IR tacrolimus following transplant. Dosing will be converted on an individual basis (Capsules: 0.5 mg, 1 mg and 5 mg or Injection: 5 mg) . All patients will be initiated on IR tacrolimus either under the tongue (sublingual) or as a solution given through a tube placed through the nose into the stomach, which is standard of care for all lung transplant recipients.

Trial Locations (1)

10016

NYU Langone Health, New York

All Listed Sponsors
lead

NYU Langone Health

OTHER

NCT04420195 - Envarsus XR in Lung Transplant | Biotech Hunter | Biotech Hunter