Myfortic in High MELD Liver Transplantation
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 4/21/2016 |
| Start Date: | March 2013 |
| End Date: | August 2015 |
Prospective Evaluation of the Efficacy and Safety of Zortress (Everolimus)/Myfortic (Enteric Coated Mycophenolate Sodium) Conversion in High MELD Liver Transplantation
The objective of the study is to determine the efficacy and safety of Everolimus conversion
in liver transplantation. Most large US liver centers transplant patients with high Model
for End-Stage Liver Disease (MELD) scores. However, many of the sponsored liver transplant
trials in the US do not include patients with high MELD scores making it difficult to
extrapolate these trial data to the patients cared for at larger liver transplant centers.
The greatest potential benefit of mammalian target of rapamycin (mTOR) inhibitors is the
avoidance of the side-effects of calcineurin-inhibitors, namely, renal insufficiency,
diabetes and hypertension. Therefore, this protocol is designed to study the efficacy and
safety of everolimus and Myfortic in liver transplant patients with high MELD scores at two
large centers with a vast experience in the administration of mTOR inhibitors.
in liver transplantation. Most large US liver centers transplant patients with high Model
for End-Stage Liver Disease (MELD) scores. However, many of the sponsored liver transplant
trials in the US do not include patients with high MELD scores making it difficult to
extrapolate these trial data to the patients cared for at larger liver transplant centers.
The greatest potential benefit of mammalian target of rapamycin (mTOR) inhibitors is the
avoidance of the side-effects of calcineurin-inhibitors, namely, renal insufficiency,
diabetes and hypertension. Therefore, this protocol is designed to study the efficacy and
safety of everolimus and Myfortic in liver transplant patients with high MELD scores at two
large centers with a vast experience in the administration of mTOR inhibitors.
Inclusion Criteria:
Patients must give written informed consent before any assessment is performed.
1. MELD ≥ 25.
2. Recipients who are 18-70 years of age of a primary or secondary liver transplant from
a deceased donor.
3. Allograft is functioning at an acceptable level by the time of randomization as
defined by the Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT),
Total Bilirubin levels ≤3 times Upper Limit of Normal (ULN), and Alkaline Phosphatase
(AlkP) levels ≤ 5 times ULN.
4. Ability and willingness to provide written informed consent and adhere to study
regimen.
5. Patients who are able to take oral medication at time of randomization. Glomerular
Filtration Rate (GFR) ≥ 30 ml/min.
Exclusion Criteria:
1. Patients receiving 3rd transplants
2. Fulminant hepatic failure
3. Living donor transplants
4. Donation after Cardiac Death (DCD) donors or split grafts
5. Active infection or hemodynamic instability at the time of transplant
6. Renal replacement therapy for clearance within 7 days prior to randomization
7. Presence of thrombosis via Doppler ultrasound of the major hepatic arteries, major
hepatic veins, portal vein and inferior vena cava.
8. An episode of acute rejection that required antibody therapy or more than one steroid
sensitive episode of acute rejection prior to randomization. This includes patients
who have not completed steroid treatment for acute rejection within 7 days prior to
randomization.
9. Spot urine protein/creatinine ratio > 1g/24h at time of randomization
10. Combined liver/kidney transplant
11. Patients who have severe hypercholesterolemia (>350 mg/dL) or Patients with platelet
count < 50,000 at time of randomization
12. Patients with an Absolute neutrophil count (ANC) of < 1,000 or White Blood Count
(WBC) of <2,000 at time of randomization
13. Patients with hemoglobin <6g/dL
14. Patients who are unable to take oral medication at time of randomization
15. Patients with clinically significant systemic infection requiring active use of IV
antibiotics, anti-virals, or anti-fungals
16. Patients who are in a critical care setting at the time of randomization requiring
life support measures such as mechanical ventilation, dialysis, requirement of
vasopressor agents
17. Known intolerance to tacrolimus or everolimus or Myfortic.
We found this trial at
1
site
University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
Click here to add this to my saved trials
