Phase II Study Evaluating the Efficacy of Tacrolimus Extended Release Tablets to Twice Daily Tacrolimus Dosing Regimen

• Status: Active, not recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This phase II, single-center, open-label study will evaluate the comparable efficacy of tacrolimus extended release tablets (Envarsus®) to the standard of care (SOC) twice daily tacrolimus (Prograf®) dosing regimen post-cardiac transplantation.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baylor Research Institute
• Treatments: Tacrolimus

Criteria

Inclusion Criteria:

• Male or female, ≥ 18 years of age

• Able to comply with medication regimen

• Subjects must have the capacity to understand and sign the informed consent form

• Heart-only transplant recipients

Exclusion Criteria:

• Subject currently enrolled in another interventional research trial

• History of hypersensitivity/adverse reaction to tacrolimus

• Patient taking Rapamycin (sirolimus) or cyclosporine (Neoral/Gengraf)

• Simultaneous multiple organ transplant recipients

• Liver transplant recipients / candidates