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Low Dose Thymoglobulin to Protect Kidney Function After Liver Transplant

NCT00970073 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-10-09

Study results available
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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

Interventions

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)

BIOLOGICAL

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

DRUG

tacrolimus 3-8

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

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.

Sponsors & Collaborators

  • Genzyme, a Sanofi Company

    collaborator INDUSTRY

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Bijan Eghtesad, MD · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2015-06-15
Completion
2015-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00970073 on ClinicalTrials.gov