Status:
COMPLETED
Low Dose Thymoglobulin to Protect Kidney Function After Liver Transplant
Lead Sponsor:
The Cleveland Clinic
Collaborating Sponsors:
Genzyme, a Sanofi Company
Conditions:
Liver Transplantation
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
This study will evaluate the use of a drug called Thymoglobulin, combined with a delayed start of the anti-rejection drugs (10 days after liver transplant), compared to the current approach of startin...
Detailed Description
Strong anti-rejection drugs like tacrolimus or cyclosporine, are given to patients who have received transplants, to ensure that the patient's body does not reject the new organ. In some cases, while ...
Eligibility Criteria
Inclusion
- Patients undergoing deceased donor solitary liver transplantation
- Adults aged 18-70 at time of transplantation
- Hepatocellular carcinoma as indication for OLT within the Milan Criteria
- Hepatitis C positive or negative patients
- Willingness to comply with study procedures
- Able to sign informed consent
Exclusion
- Prior kidney transplantation
- Congenital or iatrogenic absence of one kidney
- Subjects on renal replacement therapy at the time of OLT
- MELD score \> 28
- HIV positive patient
- Patient with current severe systemic infection
- History of bacterial peritonitis within 30 days prior to OLT
- Active infection or recent infection within 30 days prior to OLT
- Use of calcineurin inhibitor continuously for more than 90 days within the past 6 months
- History of hypersensitivity to thymoglobulin, rabbits, tacrolimus or iohexol
- Women of childbearing age who are unwilling to use effective contraceptive methods during the duration of the study
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00970073
Start Date
August 1 2009
End Date
December 1 2015
Last Update
October 9 2018
Active Locations (1)
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1
Cleveland Clinic (Main Campus)
Cleveland, Ohio, United States, 44195