NCT04420195

Envarsus XR in Lung Transplant

Pilot Study Comparing Early Conversion to Extended-Release Tacrolimus (ENVARSUS XR) to Immediate-Release Tacrolimus in Lung Transplant Recipients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Patients undergoing a lung transplant will be enrolled. All patients will undergo lung transplantation with standard post-operative management, including triple immunosuppression. As soon as the patient is deemed appropriate to take medications via the oral route, they will be converted from IR tacrolimus to Envarsus XR. Patients will be followed per site's standard of care.

Detailed description

Lung transplantation will be performed per standard-of-care techniques. All post-transplant management, including initial triple immunosuppression, will be carried out per standard of care. Once the patient is able to take medications via the oral route, they will be converted to Envarsus XR, which will be maintained for the first year post-lung transplant.

Conditions

• Lung Transplant

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-10-23
• Primary completion: 2022-11-30
• Completion: 2022-11-30
• First posted: 2020-06-09
• Last updated: 2024-01-22
• Results posted: 2024-01-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study