Low Dose Thymoglobulin to Protect Kidney Function After Liver Transplant

NCT00970073 | Completed Results

• 1 other identifier: CCIRB 09-432
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Transplantation

Keywords

calcineurin inhibitor delay; Kidney

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Patient Survival

  12 months post-transplant

• Graft Survival

  12 months post transplant

• Allograft Rejection Rates at 30 Days

  30 days

Study Arms (3)

Delayed CNI Group 1

EXPERIMENTAL

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; Drug: Mycophenolate mofetil; Drug: tacrolimus 3-8

Delayed CNI Group 2

EXPERIMENTAL

Thymoglobulin 4.5mg total, plus MMF and corticosteroids. CNI therapy delayed until 10 days post transplant.tacrolimus 3-8 (trough concentration)

Biological: Thymoglobulin 4.5mg total; Drug: Mycophenolate mofetil; Drug: tacrolimus 3-8

Early CNI / Control Arm

ACTIVE COMPARATOR

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; Drug: tacrolimus 8-12

Interventions

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)

Delayed CNI Group 1

Thymoglobulin 4.5mg total BIOLOGICAL

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

Delayed CNI Group 2

Mycophenolate mofetil DRUG

1000 mg PO/IV BID for up to 6 months

Also known as: CellCept

Delayed CNI Group 1; Delayed CNI Group 2; Early CNI / Control Arm

tacrolimus 3-8 DRUG

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

Also known as: Prograf

Delayed CNI Group 1; Delayed CNI Group 2

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.

Also known as: Prograf

Early CNI / Control Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Genzyme, a Sanofi Company: collaborator

Study Sites (1)

Cleveland Clinic (Main Campus)

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Interventions

thymoglobulin; Mycophenolic Acid; Tacrolimus

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids; Macrolides; Lactones

Results Point of Contact

• Title: Bijan Eghtesad
• Organization: Cleveland Clinic

eghtesb@ccf.org

2164029954

Study Officials

• Bijan Eghtesad, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: HPBT Staff Surgeon

Study Record Dates

• First Submitted: August 31, 2009
• First Posted: September 2, 2009
• Study Start: August 1, 2009
• Primary Completion: June 15, 2015
• Study Completion: December 1, 2015
• Last Updated: October 9, 2018
• Results First Posted: October 9, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)