Low Dose Thymoglobulin to Protect Kidney Function After Liver Transplant

Liver Transplantation Clinical Trial

Official title:

A Randomized Controlled Clinical Trial of Low Dose Thymoglobulin and Extended Delay of Calcineurin Inhibitor Therapy for Renal Protection After Liver Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00970073
• Other study ID #: CCIRB 09-432
• Status: Completed
• Phase: N/A
• Start date: August 2009
• Est. completion date: December 2015

Study information

• Verified date: September 2018
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2015
• Est. primary completion date: June 15, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Liver Transplantation

Intervention

Biological:
• Thymoglobulin 3mg total
1.5 mg/kg induction on Day 0 and 1.5 mg/kg induction on Day 2 (total of 3 mg/kg)
• Thymoglobulin 4.5mg total
1.5 mg/kg induction on Days 0, 2 and 4 (total 4.5 mg/kg)

Drug:
• Mycophenolate mofetil
1000 mg PO/IV BID for up to 6 months
• tacrolimus 3-8
Trough concentration between 3 ng/mL and 8 ng/mL starting on Day 10 and continuing beyond Day 180
• tacrolimus 8-12
Trough concentration between 8 ng/mL and 12 ng/mL on Days 0-10; between 6 ng/mL and 12 ng/mL on Days 10-30; between 6 ng/mL and 10 ng/mL Days 31-60; between 5 ng/mL and 8 ng/mL Days 61-179; and between 3 ng/mL and 8 ng/mL beyond Day 180.

Locations

Country	Name	City	State
United States	Cleveland Clinic (Main Campus)	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
The Cleveland Clinic	Genzyme, a Sanofi Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimated Glomerular Filtration Rate (eGFR) at 12 Months Post-surgery	Postoperative acute kidney injury is measured as reduced (eGFR) within 12 months post-surgery.	12 Months
Secondary	Patient Survival		12 months post-transplant
Secondary	Graft Survival	90% graft survival, related to the deaths of 3 patients during the study period.	12 months post transplant
Secondary	Allograft Rejection Rates at 30 Days	Acute Allograft Rejection	30 days