Who is sponsoring NCT05242315?

NCT05242315 is sponsored by University of Alberta.

What drugs are being tested in NCT05242315?

Interventions in NCT05242315: Envarsus Oral Product, Prograf (SOC).

What condition does NCT05242315 study?

NCT05242315 studies Liver Transplant; Complications, Renal Insufficiency, Immunosuppressant Adverse Reaction, Metabolic Syndrome, Cardiovascular Diseases.

Is NCT05242315 still recruiting?

NCT05242315 is currently recruiting now. Last updated 21 August 2025.

Last reviewed 2025-08-21 · How we verify

NCT05242315

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Extended-Release Tacrolimus Following Liver Transplantation

Recruiting now Phase 4 Last updated 21 August 2025

What this trial tests

Phase 4 trial testing Envarsus Oral Product in Liver Transplant; Complications in 94 participants. Currently enrolling.

Timeline

15 May 2022

Primary endpoint
15 December 2026

15 February 2034

Quick facts

Lead sponsor	University of Alberta
Phase	Phase 4
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	94
Start date	15 May 2022
Primary completion	15 December 2026
Estimated completion	15 February 2034
Sites	1 location across Canada

Drugs / interventions tested

Envarsus Oral Product — full drug profile →
Prograf (SOC) — full drug profile →

Conditions studied

Liver Transplant; Complications — all drugs for Liver Transplant; Complications →
Renal Insufficiency — all drugs for Renal Insufficiency →
Immunosuppressant Adverse Reaction — all drugs for Immunosuppressant Adverse Reaction →
Metabolic Syndrome — all drugs for Metabolic Syndrome →

Sponsor

University of Alberta

Who can join

18 and older, any sex, with Liver Transplant; Complications or Renal Insufficiency. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Medications used after transplant to prevent rejection are associated with many side effects. Tacrolimus side effects include kidney dysfunction; tremor, headaches, difficulty sleeping, change in sensation (legs), seizure, or confusion; high blood pressure; anemia, or low blood cell counts; diabetes; abnormal cholesterol and weight gain. The investigators want to use a new, approved, formulation of the standard medication (Envarsus) as they believe it may be associated with reduced side effects. The investigators would like to assess how safe it is to use this medication and how well it works in comparison to currently used formulations. The investigators will study if there are less side effects and will study clinical outcomes (including how well the liver does and if there is need for hospitalizations after transplant). The investigators hope that this information will improve the care provided to and outcomes in patients following liver transplant.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of Envarsus Oral Product

Trials testing the same drug.

NCT03689075 — Extended Release Versus Immediate Release Tacrolimus Following Renal Allograft Failure to Reduce Allosensitisation · Phase 4 · terminated

Other recruiting trials for Liver Transplant; Complications

Currently open trials in the same condition.

NCT06257407 — Perioperative Hemostasis Management in Liver Transplantation · recruiting
NCT06533592 — The Effect of the Type of Conduit-duct Anastomosis Technique on the Postoperative Course in Patients Undergoing Liver Tr · NA · recruiting
NCT06400771 — Safety of DNP007 in Healthy Subjects · Phase 1 · recruiting
NCT06386198 — HEalth Advocate for Liver Transplantation: Improving Transition of Care for Adolescent Liver Transplant Recipients · NA · recruiting
NCT06236568 — Impact of Graft Reconditioning With Hypothermic Machine Perfusion on HCC Recurrence After Liver Transplantation · NA · recruiting

Other University of Alberta trials

Trials by the same sponsor.

NCT03240900 — Electrical Stimulation for Improving Postoperative Breast Sensation · NA · not yet recruiting
NCT04231760 — The Effect of Inhaled Nitric Oxide on Pulmonary Gas-exchange in COPD · Phase 1, PHASE2 · not yet recruiting
NCT06649604 — Reducing Pain From Retinal Laser With Vibrational Stimulation · NA · not yet recruiting
NCT06824077 — Reducing Days DELirious With DEXmedetomidine as Part of an Intensive Care Unit Sleep Promotion Bundle · EARLY_PHASE1 · not yet recruiting
NCT06920914 — Effects of Minimally vs. Ultra-Processed Diets on Potassium (K) Handling in CKD · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05242315 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Alberta
Last refreshed: 21 August 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05242315.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing