N/A N=30 Randomized Prevention

Low Dose Thymoglobulin to Protect Kidney Function After Liver Transplant

Liver Transplantation

Bottom Line

View on ClinicalTrials.gov: NCT00970073 ↗

Enrolled (actual)

Serious AEs

6.7%

Results posted

Oct 2018

Primary outcome: Primary: Estimated Glomerular Filtration Rate (eGFR) at 12 Months Post-surgery — 72; 87.8; 51.0 mL/min

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Thymoglobulin 3mg total (Biological); Thymoglobulin 4.5mg total (Biological); Mycophenolate mofetil (Drug); tacrolimus 3-8 (Drug); tacrolimus 8-12 (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: The Cleveland Clinic
Primary completion: Jun 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Estimated Glomerular Filtration Rate (eGFR) at 12 Months Post-surgery	72; 87.8; 51.0	—
SECONDARY Patient Survival	10; 9; 8	—
SECONDARY Graft Survival	10; 9; 8	—
SECONDARY Allograft Rejection Rates at 30 Days	3; 1; 0	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00970073). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.