Low Dose Thymoglobulin to Protect Kidney Function After Liver Transplant
Completed · Not applicable
Conditions studied: Liver Transplantation
In brief
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 starting anti-rejection drugs called calcineurin inhibitors or CNI's within 2 days after the liver transplant.
Key facts
- Study ID
- NCT00970073
- Run by
- The Cleveland Clinic
- People needed
- 30
- Starts
- 2009-08-01
- Expected to finish
- 2015-12-01
- Last updated by the study team
- 2018-10-09
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Cleveland Clinic (Main Campus) — Cleveland, Ohio, United States
Full record on ClinicalTrials.gov
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