A 24 month study to test everolimus in patients who have had a liver transplant
- Conditions
- Immunosuppression in liver transplantationMedDRA version: 14.0Level: LLTClassification code 10024716Term: Liver transplantationSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 14.0Level: LLTClassification code 10021510Term: Immunosuppression NOSSystem Organ Class: 10021428 - Immune system disordersMedDRA version: 14.0Level: PTClassification code 10062016Term: ImmunosuppressionSystem Organ Class: 10021428 - Immune system disordersTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
- Registration Number
- EUCTR2007-001821-85-DE
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 690
•Ability and willingness to provide written informed consent and adhere
to study regimen.
•Recipients who are 18-70 years of age of a primary liver transplant
from a deceased donor.
•Recipients who have been initiated on an immunosuppressive regimen
that contains corticosteroids and tacrolimus, 3-7 days posttransplantation.
•Confirmed recipient HCV status at Screening (either by antibody or by
PCR).
•Allograft is functioning at an acceptable level by the time of
randomization as defined by AST, ALT, Total Bilirubin levels =3 times
ULN and AlkP and GGT = 5 times ULN. PER AM1- Elevated GGT alone,
in combination with AST, ALT, total bilirubin and AlkP within the defined
range does not exclude patients from randomization.
• Abbreviated MDRD eGFR = 30 mL/min/1.73m2. PER AM 1 Local and
central serum creatinine results obtained within 5 days prior to
randomization are acceptable, however no sooner than Day 25 posttransplantation.
• Verification of at least one tacrolimus trough level of = 8 ng/mL in the
week prior to randomization. Investigators should make adjustments in
tacrolimus dosing to continue to target trough levels above 8 ng/mL
prior to randomization.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 640
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50
•Patients who are recipients of multiple solid organ or islet cell tissue
transplants, or have previously received an organ or tissue transplant.
Patients who have a combined liver-kidney transplant.
•Recipients of a liver from a living donor, or of a split liver.
•History of malignancy of any organ system within the past 5 years
whether or not there is evidence of local recurrence or metastases, other
than non-metastatic basal or squamous cell carcinoma of the skin, or
HCC (see next criteria).
•Hepatocellular carcinoma that does not fulfill Milan criteria at the time
of transplantation as per explant histology of the recipient liver.
•Any use of antibody induction therapy.
•Patients with a known hypersensitivity to the drugs used on study or
their class, or to any of the excipients
•Patients who are recipients of ABO incompatible transplant grafts.
•Recipients of organs from donors who test positive for Hepatitis B
surface antigen or HIV are excluded.
•Patients who have any surgical or medical condition, which in the
opinion of the investigator, might significantly alter the absorption,
distribution, metabolism and excretion of study drug.
•Patients with any history of coagulopathy or medical condition
requiring long-term anticoagulation which would preclude liver biopsy
after transplantation. (Low dose aspirin treatment or interruption of
chronic anticoagulant is allowed).
•PER AM1 Patients wITH A CONFIRMED spot urine protein/creatinine
ratio that indicates = 1.0 g/24 hrs of proteinuria at baseline,AND THAT
CANNOT BE EXPLAINED BY IMMEDIATE POST OPERATIVE EFFECTS.
•Use of immunosuppressive agents or treatments after baseline that are
not utilized in the protocol.
•Patients who have severe hypercholesterolemia (>350 mg/dL; >9
mmol/L) or hypertriglyceridemia (>500 mg/dL; >8.5 mmol/L) within 6
months of transplantation. Patients with controlled hyperlipidemia are
acceptable at the time of randomization.•Patients with platelet count < 50,000/mm3 at the time of
randomization.
•Patients with an absolute neutrophil count of < 1,000/mm³ or white
blood cell count of < 2,000/mm³ at the time of randomization.
•Patients who are unable to take oral medication at time of
randomization.
•Patients who have tested positive for HIV. Negative laboratory results
obtained within 6 months prior to randomization are acceptable.
•Patients with clinically significant systemic infection requiring active
use of IV antibiotics at the time of randomization.
•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.
•Patients who require renal replacement therapy for clearance within 7
days prior to randomization.
•The presence of thrombosis via Doppler ultrasound of the major hepatic
arteries, major hepatic veins, portal vein and inferior vena cava. Results
obtained within 5 days prior to randomization are acceptable, however
no sooner than Day 25 post-transplantation.
•An episode of acute rejection that required antibody therapy or more
than one steroid-sensitive episode of acute rejection during the run-in
period. This includes patients who have not completed steroid treatment
for acute rejection within 7 days prior to randomization.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method