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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


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 donor

Security of Thymoglobuline in cadaveric donor

Secondary outcome:

Incidence of acute rejection in the recipients

Incidence 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.


Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.


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

Page last updated: August 23, 2015

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