Low Dose Thymoglobulin to Protect Kidney Function After Liver Transplant

September 10, 2018 updated by: Bijan Eghtesad, MD, The Cleveland Clinic

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic (Main Campus)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Delayed CNI Group 1
Thymoglobulin 3mg total, administered on Days 0 and 2 (after transplant), plus MMF and corticosteroids. CNI administration delayed until 10 days post transplant. tacrolimus 3-8 (trough concentration)
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)
Drug: Mycophenolate mofetil
1000 mg PO/IV BID for up to 6 months
Other Names:
  • CellCept
Drug: tacrolimus 3-8
Trough concentration between 3 ng/mL and 8 ng/mL starting on Day 10 and continuing beyond Day 180
Other Names:
  • Prograf
Experimental: Delayed CNI Group 2
Thymoglobulin 4.5mg total, plus MMF and corticosteroids. CNI therapy delayed until 10 days post transplant.tacrolimus 3-8 (trough concentration)
Drug: Mycophenolate mofetil
1000 mg PO/IV BID for up to 6 months
Other Names:
  • CellCept
Drug: tacrolimus 3-8
Trough concentration between 3 ng/mL and 8 ng/mL starting on Day 10 and continuing beyond Day 180
Other Names:
  • Prograf
Biological: Thymoglobulin 4.5mg total
1.5 mg/kg induction on Days 0, 2 and 4 (total 4.5 mg/kg)
Active Comparator: Early CNI / Control Arm
Standard post liver transplant therapy to include: tacrolimus 8-12 (trough concentration) initiated within 48 hours post-transplant, plus mycophenolate mofetil (MMF) and corticosteroids to be administered within 24 hours after transplant (Day 0).
Drug: Mycophenolate mofetil
1000 mg PO/IV BID for up to 6 months
Other Names:
  • CellCept
Drug: 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.
Other Names:
  • Prograf

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimated Glomerular Filtration Rate (eGFR) at 12 Months Post-surgery
Time Frame: 12 Months
Postoperative acute kidney injury is measured as reduced (eGFR) within 12 months post-surgery.
12 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Survival
Time Frame: 12 months post-transplant
12 months post-transplant
Graft Survival
Time Frame: 12 months post transplant
90% graft survival, related to the deaths of 3 patients during the study period.
12 months post transplant
Allograft Rejection Rates at 30 Days
Time Frame: 30 days
Acute Allograft Rejection
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Collaborators

Genzyme, a Sanofi Company

Investigators

  • Principal Investigator: Bijan Eghtesad, MD, The Cleveland Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2009

Primary Completion (Actual)

June 15, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

August 31, 2009

First Submitted That Met QC Criteria

September 1, 2009

First Posted (Estimate)

September 2, 2009

Study Record Updates

Last Update Posted (Actual)

October 9, 2018

Last Update Submitted That Met QC Criteria

September 10, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCIRB 09-432

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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