Thymoglobulin in Cadaver Donor
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|ClinicalTrials.gov Identifier: NCT01939171|
Recruitment Status : Completed
First Posted : September 11, 2013
Last Update Posted : September 11, 2013
|Condition or disease||Intervention/treatment||Phase|
|Prevention of Kidney Injury Associated With Brain Death||Drug: Thymoglobulin||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Conditioning of the Cadaver Donor by Thymoglobulin Administered to Reduce the Pro-inflammatory State After Brain Death.|
|Study Start Date :||June 2010|
|Actual Primary Completion Date :||February 2012|
|Actual Study Completion Date :||February 2012|
Placebo Comparator: Non treated
Cadaver donor is cared and treated as usual protocol
Cadaver donor receives one dose of thymoglobulin of 3 mg/kg iv in 2 hours after ganglia extraction and 3- 6 hours prior to organ procurement.
- Efficacy of Thymoglobuline in cadaveric donor [ Time Frame: 2 days ]To determine the efficacy of Thymoglobuline in cadaveric donor Efficacy: To demonstrate that in cadaveric donor, Thymoglobuline diminished graft alloreactivity by decreasing expression of inflammatory markers(determining HLA-DR,VCAM-1, ICAM-1 expressions by immunohistochemistry in graft biopsies), and the rates of delayed graft function and cellular/humoral rejection demonstrated by biopsy.
- Security of Thymoglobuline in cadaveric donor [ Time Frame: 1 day ]Estimated by general and particularly hemodynamic tolerance to thymoglobulin infusion.
- Incidence of acute rejection in the recipients [ Time Frame: 3 moths ]To demonstrate that in cadaveric donors, Thymoglobuline tends to decrease the incidence of acute rejection demonstrated by kidney biopsy.
- Incidence of delayed graft function in the recipients. [ Time Frame: 1 month ]To demonstrate that in cadaveric donors, Thymoglobuline tends to decrease the incidence of DGF estimated by the necessity of dialysis after transplantation.
- Composite of incidence of graft function and general effects in the recipients. [ Time Frame: 1 year ]To demonstrate that Thymoglobuline administered in cadaveric donors does not have neither repercussion on graft function nor side effects in renal and liver recipients.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01939171
|Hospital Santa Maria|
|Lisbon, Portugal, 1649-035|
|Hospital Universitario La Paz|
|Madrid, Spain, 28046|
|Principal Investigator:||Carlos Jimenez, MD, PhD||Hospital Universitario La Paz|
|Principal Investigator:||Maria Lopez-Oliva, MD||Hospital Universitario La Paz|
|Principal Investigator:||Rui Mayo, MD||Hospital Santa Maria, Portugal|