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NCT01939171 Clinical Trial

Thymoglobulin in Cadaver Donor

Prevention of Kidney Injury Associated With Brain Death Clinical Trial

Official title:
Conditioning of the Cadaver Donor by Thymoglobulin Administered to Reduce the Pro-inflammatory State After Brain Death.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01939171
Other study ID # HULP- Nefro 001
Secondary ID 2009-013398-16
Status Completed
Phase Phase 2
First received August 29, 2013
Last updated September 5, 2013
Start date June 2010
Est. completion date February 2012

Study information
Verified date September 2013
Source Instituto de Investigación Hospital Universitario La Paz
Contact n/a
Is FDA regulated No
Health authority Spain: Agencia Española de Medicamentos y Productos Sanitarios
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date February 2012
Est. primary completion date February 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• Thymoglobulin

Locations
Country Name City State
Portugal Hospital Santa Maria Lisbon
Spain Hospital Universitario La Paz Madrid

Sponsors (2)
Lead Sponsor Collaborator
Instituto de Investigación Hospital Universitario La Paz Hospital de Santa Maria, Portugal

Countries where clinical trial is conducted

Portugal,  Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
Primary Security of Thymoglobuline in cadaveric donor Estimated by general and particularly hemodynamic tolerance to thymoglobulin infusion. 1 day Yes
Secondary Incidence of acute rejection in the recipients To demonstrate that in cadaveric donors, Thymoglobuline tends to decrease the incidence of acute rejection demonstrated by kidney biopsy. 3 moths No
Secondary Incidence of delayed graft function in the recipients. To demonstrate that in cadaveric donors, Thymoglobuline tends to decrease the incidence of DGF estimated by the necessity of dialysis after transplantation. 1 month No
Secondary Composite of incidence of graft function and general effects in the recipients. To demonstrate that Thymoglobuline administered in cadaveric donors does not have neither repercussion on graft function nor side effects in renal and liver recipients. 1 year Yes

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