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NCT05655273
Conversion of Maintenance Prograf to Envarsus in Liver Transplant Recipients
Phase 4 trial testing Prograf in Liver Transplant Rejection in 40 participants. Enrolling by invitation.
30 April 2025
Quick facts
| Lead sponsor | University Health Network, Toronto |
|---|---|
| Phase | Phase 4 |
| Status | ENROLLING BY INVITATION |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 1 January 2024 |
| Primary completion | 30 April 2025 |
| Estimated completion | 28 February 2026 |
| Sites | 1 location across Canada |
Drugs / interventions tested
Conditions studied
- Liver Transplant Rejection — all drugs for Liver Transplant Rejection →
- Immune System Suppression — all drugs for Immune System Suppression →
Sponsor
University Health Network, Toronto
Who can join
Adults 18 to 99, any sex, with Liver Transplant Rejection or Immune System Suppression. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Prograf and Envarsus are two different formulations of Tacrolimus which is used as an immunosuppressant in liver transplant (LT) patients. Prograf is currently used as part of the standard immunosuppression regimen for LT recipients at UHN. This study will compare the use of Prograf and Envarsus and their effects on liver and renal function, trough tacrolimus levels, drug-related adverse effects, and patient adherence. Trial design is a pilot randomized trial. The study aims to recruit 40 patients from UHN's LT program and they will be randomized 1:1 to either stay on their current dose of Prograf or be converted to a once-daily equivalent dose of Envarsus. Both groups of patients will be followed for 48 weeks. This study will compare the change from baseline to week 48 in liver and renal function, tacrolimus-related side effects and patient reported outcomes between the two study groups.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05655273
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Prograf
Trials testing the same drug.
- NCT03828058 — Envarsus XL Immunosuppression Following Liver Transplantation · Phase 2 · completed
- NCT02866682 — Prospective Study Comparing Brand and Generic Immunosuppression on Transplant Outcomes, Adherence, & Immune Response in · Phase 4 · completed
- NCT03216447 — A Study of Patient Adherence and Convenience to Immunosuppressive Agents in Newly Liver Transplant · Phase 4 · unknown
- NCT02251691 — Influence of Once-daily Versus Twice-daily Immunosuppressant on Renal Transplant · Phase 4 · unknown
- NCT02268201 — A Study to Evaluate the Efficacy and Safety in Kidney Transplant Recipients When Changed From Cyclosporine to Tacrolimus · Phase 4 · terminated
Other recruiting trials for Liver Transplant Rejection
Currently open trials in the same condition.
- NCT07053488 — CRISPR-Edited HLA Donor Liver Transplant to Reduce Rejection · Phase 1, PHASE2 · recruiting
- NCT06400771 — Safety of DNP007 in Healthy Subjects · Phase 1 · recruiting
- NCT05325073 — Erythropoietin Therapy to Induce Regulatory T Cells in Liver Transplant Recipients · Phase 4 · active not recruiting
- NCT06153641 — Cytokeratin 18 Non-invasive Biomarker for Rejection in Liver Transplant Patients · active not recruiting
Other University Health Network, Toronto trials
Trials by the same sponsor.
- NCT06831032 — Elective Adaptive Radiation With SBRT for Improved DurabilitY of Response · NA · recruiting
- NCT06634056 — Pneumonitis Prevention Protocol Using Pentoxifylline and α-tocopherol In Stage III Non-Small Cell Lung Cancer Patients U · Phase 2 · not yet recruiting
- NCT06836726 — Clinical Trial to Test Efficacy of Targeting Hypoxia Combined With ARSI After First-line ARSI Therapy for Castrate Resis · Phase 2 · not yet recruiting
- NCT07515651 — Molecular Imaging Informed Radiation Dose Escalation to Sites of Recurrent Disease and De-escalation to Uninvolved Areas · Phase 2 · not yet recruiting
- NCT07509450 — Fecal Microbiota Transplantation in Patients Undergoing Chimeric Antigen Receptor T-cell Therapy and Allogeneic Stem Cel · 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)
- Trial protocol + status: ClinicalTrials.gov NCT05655273 (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 Health Network, Toronto
- Last refreshed: 11 December 2024
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/NCT05655273.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing