Clinical trial NCT00970073: Low Dose Thymoglobulin to Protect Kidney Function After Liver Transplant
Official title: A Randomized Controlled Clinical Trial of Low Dose Thymoglobulin and Extended Delay of Calcineurin Inhibitor Therapy for Renal Protection After Liver Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Transplantation
Keywords: calcineurin inhibitor delay
Kidney
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: Genzyme, a Sanofi Company
First posted: 2009-09-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 starting anti-rejection drugs called calcineurin inhibitors or CNI's within 2 days after the liver transplant.

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 anti-rejection medications protect a newly transplanted liver, they can injure the patient's kidneys and cause them not to work as well as they should. The purpose of this pilot study is to determine the best way to protect kidney function and to ensure that the newly transplanted liver is not rejected. 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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Estimated Glomerular Filtration Rate (eGFR) at 12 Months Post-surgery
timeFrame: 12 Months
Secondary outcomes:
measure: Patient Survival
timeFrame: 12 months post-transplant
measure: Graft Survival
timeFrame: 12 months post transplant
measure: Allograft Rejection Rates at 30 Days
timeFrame: 30 days
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic (Main Campus)
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Bijan Eghtesad, MD
role: PRINCIPAL_INVESTIGATOR
References: