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Completed

NCT Number: NCT00970073

Low Dose Thymoglobulin to Protect Kidney Function After Liver Transplant

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic (Main Campus)

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thymoglobulin 3mg total

Biological

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

Biological

1.5 mg/kg induction on Days 0, 2 and 4 (total 4.5 mg/kg)

Mycophenolate mofetil

Drug

1000 mg PO/IV BID for up to 6 months

Other names: CellCept

tacrolimus 3-8

Drug

Trough concentration between 3 ng/mL and 8 ng/mL starting on Day 10 and continuing beyond Day 180

Other names: Prograf

tacrolimus 8-12

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Patient Survival

    Time frame: 12 months post-transplant

  2. Graft Survival

    Time frame: 12 months post transplant

    90% graft survival, related to the deaths of 3 patients during the study period.

  3. Allograft Rejection Rates at 30 Days

    Time frame: 30 days

    Acute Allograft Rejection

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Collaborators

  • Genzyme, a Sanofi Company

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Sep 2, 2009
Registry last updated
Oct 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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