Thymoglobulin in Cadaver Donor
Information source: Instituto de Investigación Hospital Universitario La Paz
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Prevention of Kidney Injury Associated With Brain Death
Intervention: Thymoglobulin (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Instituto de Investigación Hospital Universitario La Paz Official(s) and/or principal investigator(s): Carlos Jimenez, MD, PhD, Principal Investigator, Affiliation: Hospital Universitario La Paz Maria Lopez-Oliva, MD, Principal Investigator, Affiliation: Hospital Universitario La Paz Rui Mayo, MD, Principal Investigator, Affiliation: Hospital Santa Maria, Portugal
Summary
To determine the efficacy and Security of Thymoglobuline in cadaveric donor Efficacy: To
demonstrate that in cadaveric donor, Thymoglobuline diminished graft alloreactivity by
decreasing expression of inflammatory markers in graft biopsies Security: To demonstrate that
the administration of Thymoglobulin does not have side effects in renal recipients.
Clinical Details
Official title: Conditioning of the Cadaver Donor by Thymoglobulin Administered to Reduce the Pro-inflammatory State After Brain Death.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Efficacy of Thymoglobuline in cadaveric donorSecurity of Thymoglobuline in cadaveric donor
Secondary outcome: Incidence of acute rejection in the recipientsIncidence of delayed graft function in the recipients. Composite of incidence of graft function and general effects in the recipients.
Detailed description:
This is randomized controlled Multicenter phase II clinical trial promoted by members from
IdiPAZ. At least two hospital (La Paz and Santa Maria from Lisbon, will be involved. A per
nature pilot study will recruit 10 cadaver donors from each hospital, and randomized
half-to-half per center, for study and control groups.
The RCT initiated in 2009 and finished in 2013.
Cadaver donor from the study group will receive 3 mg/kg iv. Thymoglobulin 3-6 hours prior to
organ procurement. The randomization process recruits 1: 1 study/control donors.
Kidney biopsies will be taken from each kidney before transplantation to examine the
expression of pro-inflammatory and HLA molecules (anti-DR, VCAM, ICAM, E-selectin) at
tubular cells by immunohistochemical techniques under blinded conditions.
Recipients will be managed as usual and expressly followed up for one year, recording the
incidence of delayed graft function and rejection and graft survival at the first year.
A comparison between the results obtained in kidney biopsies and patients transplanted in
each group will permit differentiate whether Thymoglobulin administered in cadaver modifies
the expression of antigens by kidney tubular cells and the results obtained with
transplantation, in terms of graft function, rejection and survival.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Accepted adults cadaveric donors for renal transplant from University Hospital La
Paz( Madrid) and from University Hospital Santa Maria (Lisbon)
- Informed consent from relatives for including in the study
Exclusion Criteria:
- Known allergy to the rabbit proteins
- Non accepted grafts
- Family refusal to consent
Locations and Contacts
Hospital Santa Maria, Lisbon 1649-035, Portugal
Hospital Universitario La Paz, Madrid 28046, Spain
Additional Information
Medical Research Institute General Public University Hospital General Public University Hospital
Starting date: June 2010
Last updated: September 5, 2013
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