Thymoglobulin in Cadaver Donor
Conditioning of the Cadaver Donor by Thymoglobulin Administered to Reduce the Pro-inflammatory State After Brain Death.
2 other identifiers
interventional
20
2 countries
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jun 2010
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 29, 2013
CompletedFirst Posted
Study publicly available on registry
September 11, 2013
CompletedSeptember 11, 2013
September 1, 2013
1.7 years
August 29, 2013
September 5, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Efficacy of Thymoglobuline in cadaveric donor
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.
2 days
Security of Thymoglobuline in cadaveric donor
Estimated by general and particularly hemodynamic tolerance to thymoglobulin infusion.
1 day
Secondary Outcomes (3)
Incidence of acute rejection in the recipients
3 moths
Incidence of delayed graft function in the recipients.
1 month
Composite of incidence of graft function and general effects in the recipients.
1 year
Study Arms (2)
Non treated
PLACEBO COMPARATORCadaver donor is cared and treated as usual protocol
TREATED
EXPERIMENTALCadaver 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Known allergy to the rabbit proteins
- Non accepted grafts
- Family refusal to consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Hospital Santa Maria
Lisbon, Lisbon District, 1649-035, Portugal
Hospital Universitario La Paz
Madrid, Madrid, 28046, Spain
Related Links
MeSH Terms
Interventions
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 29, 2013
First Posted
September 11, 2013
Study Start
June 1, 2010
Primary Completion
February 1, 2012
Study Completion
February 1, 2012
Last Updated
September 11, 2013
Record last verified: 2013-09