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Clinical trial

Prograf/Envarsus Conversion Study in Liver Transplant Recipients to Improve Side Effects, Adherence and Quality of Life: A Single-centre Randomized Controlled Trial

ID
Name
22-5210
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.
Trial arms
Trial start
2023-06-01
Estimated PCD
2023-12-31
Trial end
2024-10-31
Status
Not yet recruiting
Phase
Early phase I
Treatment
Prograf
Participants randomized to the Prograf (control) arm will continue with their current twice daily dosing of Prograf.
Arms:
Post-liver transplant patients receiving Prograf
Envarsus
Participants randomized to Envarsus arm will have their current daily dose of Prograf converted to once-daily Envarsus dose according to the following ratio: 0.7 x the current daily Prograf dose. Envarsus is available in 3 dose strengths- 0.75mg, 1.0mg, and 4.0mg. The actual dose of Envarsus will be rounded to an amount that can be administered using the above tablet strengths.
Arms:
Post-liver transplant patients receiving Envarsus
Size
40
Primary endpoint
Change in AST levels
Baseline to week 12
Change in ALT levels
Baseline to week 12
Change in ALP levels
Baseline to week 12
Change in Bilirubin blood levels
Baseline to week 12
Change in tacrolimus trough levels
Baseline to week 12
Change in overall daily dose of tacrolimus
Baseline to week 12
Eligibility criteria
Inclusion Criteria: * Adult (\>18 years) prevalent liver transplant recipient * \>12 months after liver transplant * Prograf-based maintenance immunosuppression with targeted tacrolimus trough level of 5-10 ug/L * Stable liver allograft function (defined as ASL \& ALT \<30, Bilirubin \<20 \& ALP\<150 at baseline visit or within 4 weeks of baseline visit) * Stable renal function (creatinine \< 180 µmol/l and eGFR \> 40 ml/min) at baseline visit (or within 4 weeks of baseline visit) * No episode of acute rejection within 6 months of baseline visit * Elevated creatinine (defined as \>ULN) OR Significant symptoms (by patient self-report) potentially associated with tacrolimus (eg. tremor, difficulty to concentrate, insomnia) OR difficulty to adhere to a twice daily regimen Exclusion Criteria: * Multiorgan transplant; * severe intercurrent illness; * severe cognitive impairment (all as determined by clinical team); * unwilling to consent.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'conversion v. control', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}
Updated at
2023-05-15

1 organization

1 product

1 drug

2 indications

Organization
University Health Network
Drug
tacrolimus
Indication
Liver Transplant Rejection
Indication
Immune System Suppression
Product
Envarsus