CompletedPhase 2

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

United States50 participantsStarted 2017-12-04

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Rejection and Graft Failure

Timeframe: 2 years

Trial details

NCT IDNCT03373227

SponsorBaylor Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-30

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