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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
Sponsor:
Collaborator:
Hospital de Santa Maria, Portugal
Information provided by (Responsible Party):
Instituto de Investigación Hospital Universitario La Paz

Study Description
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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.

Condition or disease Intervention/treatment Phase
Prevention of Kidney Injury Associated With Brain Death Drug: Thymoglobulin Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Non treated
Cadaver donor is cared and treated as usual protocol
Experimental: TREATED
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.
 Drug: Thymoglobulin


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. Security of Thymoglobuline in cadaveric donor [ Time Frame: 1 day ]
    Estimated by general and particularly hemodynamic tolerance to thymoglobulin infusion.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Portugal
Hospital Santa Maria
Lisbon, Portugal, 1649-035
Spain
Hospital Universitario La Paz
Madrid, Spain, 28046
Sponsors and Collaborators
Instituto de Investigación Hospital Universitario La Paz
Hospital de Santa Maria, Portugal
Investigators
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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
More Information
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Additional Information:

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Responsible Party: Instituto de Investigación Hospital Universitario La Paz
ClinicalTrials.gov Identifier: NCT01939171    
Other Study ID Numbers: HULP- Nefro 001
2009-013398-16 ( EudraCT Number )
First Posted: September 11, 2013    Key Record Dates
Last Update Posted: September 11, 2013
Last Verified: September 2013
Keywords provided by Instituto de Investigación Hospital Universitario La Paz:
Thymoglobulin
Cadaver donor
Kidney injury brain death related
Additional relevant MeSH terms:
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Brain Death
Death
Cadaver
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Coma
 Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Thymoglobulin
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents