Status:
COMPLETED
Examination of Immunosuppression Adjustment Impact on Kidney Function in Liver Transplant
Lead Sponsor:
Fady M Kaldas, M.D., F.A.C.S.
Conditions:
Asses Immunosuppression Modulation on Renal Recovery Post LT
Eligibility:
All Genders
18-78 years
Phase:
PHASE4
Brief Summary
This is a study to help understand how well new combinations of immunosuppressive medications (medications that weaken your immune system to prevent your body from rejecting the transplanted liver) wo...
Detailed Description
A single center, open label, randomized, prospective, pilot study of induction and maintenance immunosuppression in adult subjects \>18 years undergoing orthotopic liver transplantation (OLT) with Bas...
Eligibility Criteria
Inclusion
- Patients eligible for inclusion in this study have to fulfill all of the following criteria:
- A signed informed consent prior to patient participation in the study and before any assessment is performed.
- Patients who are able to take oral medication.
- 18 years old
- Undergoing first OLT
- Dialysis for 45 days or less at time of transplant
- Able and willing to conform to requirements of the study
- Able and willing to provide informed consent
Exclusion
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- \< 18 years old
- Autoimmune liver disease, Primary Sclerosing Cholangitis, Primary Biliary Cirrhosis
- Dialysis greater than 45 days
- Receiving ATG, IVIG therapy, or sirolimus/everolimus around time of transplant or sirolimus/everolimus after transplant
- Unable to take oral medications
- Participating in another clinical research study involving the evaluation of another investigational drug or device
- Documented allergy to basiliximab, TAC, MMF or any macrolide antibiotic.
- Presence of thrombosis of any major hepatic arteries
- Complex/high risk arterial reconstruction at any time (graft vessel patency by Doppler ultrasound confirmed and documented).
- Patients who are recipients of multiple solid organ transplants, (e.g., multivisceral or combined liver-kidney transplants), or have previously received an organ or tissue transplanted, or who received an ABO incompatible transplant.
- Patients who have severe hypercholesterolemia (\>215 mg/dL; \>5.5 mmol/L) or hypertriglyceridemia (\>265 mg/dL; \>3.0 mmol/L) at Baseline.
- Patients who have severe thrombocytopenia or neutropenia (platelet count \>20 and MLCs\>1000)
- 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 drugs
- Patients with a known hypersensitivity to the drugs used on study or their class, or to any of the excipients.
- Patients with clinically significant systemic infection
- Pregnant or nursing (lactating) female patients, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive βHCG laboratory test (\>9 mIU/mL) at Baseline.
Key Trial Info
Start Date :
January 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2024
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT04104438
Start Date
January 15 2021
End Date
September 30 2024
Last Update
December 16 2025
Active Locations (1)
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1
UCLA Medical Center
Los Angeles, California, United States, 90095