Clinical trial NCT01939171: Thymoglobulin in Cadaver Donor
Official title: Conditioning of the Cadaver Donor by Thymoglobulin Administered to Reduce the Pro-inflammatory State After Brain Death.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prevention of Kidney Injury Associated With Brain Death
Keywords: Thymoglobulin
Cadaver donor
Kidney injury brain death related
Lead sponsor: Instituto de Investigación Hospital Universitario La Paz
Sponsor class: OTHER
Collaborators: name: Hospital de Santa Maria, Portugal
First posted: 2013-09-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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 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

Primary outcomes:
measure: Efficacy of Thymoglobuline in cadaveric donor
timeFrame: 2 days
measure: Security of Thymoglobuline in cadaveric donor
timeFrame: 1 day
Secondary outcomes:
measure: Incidence of acute rejection in the recipients
timeFrame: 3 moths
measure: Incidence of delayed graft function in the recipients.
timeFrame: 1 month
measure: Composite of incidence of graft function and general effects in the recipients.
timeFrame: 1 year
Other outcomes:
Locations:
city: Lisbon
country: Portugal
facility: Hospital Santa Maria
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
Study officials:
affiliation: Hospital Universitario La Paz
name: Carlos Jimenez, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario La Paz
name: Maria Lopez-Oliva, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Santa Maria, Portugal
name: Rui Mayo, MD
role: PRINCIPAL_INVESTIGATOR
References: