Examining adherence to immunosuppressive medications in new liver transplant patients
A Prospective, Multi-center, Open-labeled, Randomized Clinical Trial of Patient Adherence and Convenience to Immunosuppressive Agents in Newly Liver Transplant Recipients to Compare QD Early Conversion and BID Tacrolimus Formulation.
This study is testing whether new liver transplant patients stick to taking their daily immunosuppressive medications better with a once-a-day pill compared to a twice-a-day pill.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Chang Gung Memorial Hospital Academic / other |
| Locations | 1 site (Taoyuan) |
| Trial ID | NCT03216447 on ClinicalTrials.gov |
What this trial studies
This study investigates how well newly transplanted liver patients adhere to immunosuppressive medications, specifically comparing a once-daily formulation (Advagraf®) to a twice-daily formulation (Prograf). It is a prospective, multi-center, open-labeled, randomized clinical trial that will enroll participants in Taiwan. Patients will be randomized on postoperative day 15 to assess their adherence and convenience with the medication regimen. The study aims to improve patient outcomes by optimizing medication adherence in this population.
Who should consider this trial
Good fit: Ideal candidates are primary liver transplant recipients aged 20 to 70 who can understand and follow study procedures.
Not a fit: Patients who have received other organ transplants or have certain medical conditions, such as requiring dialysis or being HIV positive, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance medication adherence and improve health outcomes for liver transplant recipients.
How similar studies have performed: Other studies have shown that optimizing immunosuppressive medication regimens can improve adherence and outcomes, suggesting this approach has potential.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient has been fully informed and has signed an IRB approved informed consent form within 7 days (Day 7-13) prior to POD 15 and is willing and able to follow study procedure * Patient is a primary liver transplant recipient * Patient is 20 to 70 years of age * Patient should be clearly conscious, fully understand and able to answer questionnaire Exclusion Criteria: * Patient has previously received or is receiving an organ transplant other than a liver. * Patient currently requires dialysis * Recipient or donor is known to be seropositive for human immunodeficiency virus (HIV) * Patient has received a liver transplant from a non-heart beating donor * Patient who is HCV negative has received an HCV positive (HCV RNA by PCR or HCV antibody) donor liver * Patient who is HbsAg negative has received an HbsAg positive (HBV DNA by PCR or HBV antibody) donor liver * Patient has received a liver transplant from a decrease donor \> 70 years of age * Patient has a current malignancy or a history of malignancy (within the past 5 years), except hepatocellular carcinoma within UCSF Criteria and basal or non-metastatic squamous cell carcinoma of skin that has been treated successfully. * Patient is hemodynamically unstable on POD 15
Where this trial is running
Taoyuan
- Chang Gung Memorial Hospital — Taoyuan, Taiwan (Recruiting)
Study contacts
- Principal investigator: Wei-Chen Lee — Cgmh
- Study coordinator: Wei-Chen Lee
- Email: weichen@cgmh.org.tw
- Phone: 09753-68195
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.