Liver Transplantation Clinical Trial
— LCP-TACOfficial title:
Tacrolimus Associated Tremors in Liver Transplant Recipients: a Randomized Open Label Trial Comparing De Novo Extended-release Once Daily (LCP-TAC) and Twice Daily Immediate-release (IR-TAC) Tacrolimus Formulations
This is a randomized open label study in de novo liver transplant recipients that aims to compare the risk of tacrolimus induced tremors with once daily extended-release formulation, Envarsus, versus the twice daily immediate-release formulation. Both formulations of tacrolimus are currently approved for the prevention of rejection in liver transplant patients.
Status | Recruiting |
Enrollment | 124 |
Est. completion date | December 31, 2026 |
Est. primary completion date | January 1, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Adults aged 18 years or older 2. Recipients of a first-time liver transplant 3. eGFR more than 30 ml/min on the day of tacrolimus initiation 4. All patients who are eligible to initiate Tacrolimus within 7 days post-liver transplant 5. Informed consent Exclusion Criteria: 1. Recipients of prior organ transplant 2. Need for hemodialysis either prior or following liver transplantation 3. Recipients of living donor liver or split deceased donor liver allografts 4. Recipients of combined liver/kidney transplants 5. Recipients receiving liver allografts from donors with HCV viremia (detected through nucleic acid testing or other means) 6. Patients with a history of tremor prior to transplantation including essential tremors, Parkinson's or Parkinsonian syndromes 7. Patients receiving concomitant medications known to induce tremors such as dopamine blocking agents 8. Baseline TSH, T3, T4 indicating hyperthyroidism |
Country | Name | City | State |
---|---|---|---|
Canada | Vancouver General Hospital | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
University of British Columbia | Paladin Labs Inc. |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Incidence of biopsy proven acute cellular rejection (BPAR) | Incidence of biopsy proven acute cellular rejection (BPAR) by Banff 97 criteria | 3, 6 and 12 months post transplantation | |
Other | Incidence and severity of AKI | Incidence and severity of AKI based on KDIGO classification | 1,3 and 6 months post transplant | |
Other | eGFR (MDRD) < 45 mL/min and < 30 mL/min | Proportion of patients with eGFR (MDRD) < 45 mL/min and < 30 mL/min | 6 & 12 months after transplant | |
Other | Change in GFR | Change in GFR from month 1 (day 28) to month 12 (day 364) | 12 months after transplant | |
Other | Incidence of new onset diabetes after transplantation (NODAT) | Incidence of new onset diabetes after transplantation (NODAT) | 6 and 12 months post transplant | |
Other | Severity of tremors | Proportion of patients with mild, moderate and severe tremor | 2, 4, 6 and 8 weeks after transplantation | |
Primary | Proportion of patients with tacrolimus induced tremors or worsening tremors or tacrolimus discontinuation due to neurotoxicity at 8 weeks post transplantation | Composite end point of proportion of patients with new tremor as defined by Kinesia One average score of 1 or greater or an increase from baseline of greater than or equal to 1 point at week 8 after transplantation, or tacrolimus discontinuation due to neurotoxicity (tremor, headaches, seizure or dysarthria). | 8 weeks post transplantation | |
Secondary | Proportion of patients reaching the composite end point of death, graft loss or biopsy proven acute cellular rejection (BPAR) at 12 months post transplantation | The proportion of patients reaching the composite end point of death, graft loss or biopsy proven acute cellular rejection (BPAR) | 12 months post transplantation | |
Secondary | Tremor related quality of life satisfaction as assessed by the Quality of Life in Essential Tremor (QUEST) scale | The Quality of Life in Essential Tremor (QUEST) is a 30 item scale rated on five-point scale (0-4), corresponding to the frequency (never, rarely, sometimes, frequently, always) with scores ranging from 0 to 120. Higher scores indicate greater dissatisfaction or disability. | 8 weeks post transplantation | |
Secondary | Immunosuppression medication adherence as assessed by the Simplified Medication Adherence Questionnaire (SMAQ) at 8 weeks after transplant | Simplified Medication Adherence Questionnaire (SMAQ) consists of six questions evaluating different aspects of patient adherence, such as forgetfulness, routine and adverse events. SMAQ is a self-reported questionnaire that has been validated in transplant population. Patients are considered adherent if they reply to all questions with an adherent answer in all six SMAQ items. (ie 1-"yes" , 2-4 - "no", not having missed more than 2 doses during last week or having failed to take the medication on not more than 2 days during the last 3 months.
We are measuring SMAQ twice for this study (at 8 weeks and again at 12 months). Based on the literature, transplant patients are more likely to be adherent early after transplantation but they become progressively less adherent with time after transplant. We would like to determine if once daily tacrolimus has any impact on adherence. |
8 weeks post transplant | |
Secondary | Immunosuppression medication adherence as assessed by the Simplified Medication Adherence Questionnaire (SMAQ) at 12 months after transplant | Simplified Medication Adherence Questionnaire (SMAQ) consists of six questions evaluating different aspects of patient adherence, such as forgetfulness, routine and adverse events. SMAQ is a self-reported questionnaire that has been validated in transplant population. Patients are considered adherent if they reply to all questions with an adherent answer in all six SMAQ items. (ie 1-"yes" , 2-4 - "no", not having missed more than 2 doses during last week or having failed to take the medication on not more than 2 days during the last 3 months.
We are measuring SMAQ twice for this study (at 8 weeks and again at 12 months). Based on the literature, transplant patients are more likely to be adherent early after transplantation but they become progressively less adherent with time after transplant. We would like to determine if once daily tacrolimus has any impact on adherence. |
12 months post transplantation |
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