Prevention of Kidney Injury Associated With Brain Death Clinical Trial
Official title:
Conditioning of the Cadaver Donor by Thymoglobulin Administered to Reduce the Pro-inflammatory State After Brain Death.
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.
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention