ACONDICIONAMIENTO DEL DONANTE CADÁVER MEDIANTE LA ADMINISTRACIÓN DE TIMOGLOBULINA PARA DISMINUIR EL ESTADO PRO-INFLAMATORIO TRAS LA MUERTE CEREBRAL

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-013398-16-ES

Enrollment

Registered

2009-08-27

Start date

2009-11-16

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eficacia: Demostrar que la administración de timoglobulina en el donante cadáver reduce la expresividad antigénica del injerto, mediante una disminución de la expresión de marcadores de inflamación en la biopsia de los injertos. Seguridad: demostrar que la administración de timoglobulina en el donante cadáver no provoca efectos secundarios en los receptores de riñón.

Interventions

Trade Name: TIMOGLOBULINA Pharmaceutical Form: Powder and solvent for solution for infusion INN or Proposed INN: AGUA PARA PREPARACIONES INYECTABLES Other descriptive name: AGUA PARA PREPARACIONES INY

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Accepted adults cadaveric donors from Universitary Hospital La Paz( Madrid) and from Universitary Hospital Santa Maria (Lisbon) - Informed consent from relatives for including in the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Known allergy to the rabbit proteins - Non accepted grafts

Design outcomes

Primary

Measure	Time frame
Main Objective: 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.;Secondary Objective: To demonstrate that in cadaveric donors, Thymoglobuline tends to decrease the incidence of acute rejection and DGF To know the mode of action "in vitro"of Thymoglobuline over tubular cells culture and in an animal model of IR injury;Primary end point(s): - Decreased of : VCAM;anti-DR,ICAM and E-selectine in graft biopsies measured by immunohystochemic analysis - Graft and patient Survival at 12 m	—

Measure

Time frame

Main Objective: 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.;Secondary Objective: To demonstrate that in cadaveric donors, Thymoglobuline tends to decrease the incidence of acute rejection and DGF To know the mode of action "in vitro"of Thymoglobuline over tubular cells culture and in an animal model of IR injury;Primary end point(s): - Decreased of : VCAM;anti-DR,ICAM and E-selectine in graft biopsies measured by immunohystochemic analysis - Graft and patient Survival at 12 m

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Countries

Spain

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026