Completed

NCT Number: NCT01939171

Thymoglobulin in Cadaver Donor

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.

Completed

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Key information

Conditions

Prevention of Kidney Injury Associated With Brain Death

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital Santa Maria, Lisbon, Lisbon District, Portugal

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thymoglobulin

Drug

Primary outcomes

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.
Security of Thymoglobuline in cadaveric donor

Time frame: 1 day

Estimated by general and particularly hemodynamic tolerance to thymoglobulin infusion.

Secondary outcomes

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.
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.
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.

Sponsors and collaborators

Lead sponsor

Instituto de Investigación Hospital Universitario La Paz

Other

Collaborators

Hospital de Santa Maria, Portugal

Registry information

Official study title

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

Important dates

Study start: 2010
Primary completion: 2012
Study completion: 2012
First posted: Sep 11, 2013
Registry last updated: Sep 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.