MedDataX Logo

Thymoglobulin in Cadaver Donor

NCT ID: NCT01939171

Last Updated: 2013-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2012-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prevention of Kidney Injury Associated With Brain Death

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Thymoglobulin Cadaver donor Kidney injury brain death related

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Non treated

Cadaver donor is cared and treated as usual protocol

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Thymoglobulin

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Thymoglobulin

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hospital de Santa Maria, Portugal

OTHER

Sponsor Role collaborator

Instituto de Investigación Hospital Universitario La Paz

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Carlos Jimenez, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario La Paz

Maria Lopez-Oliva, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario La Paz

Rui Mayo, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Santa Maria, Portugal

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital Santa Maria

Lisbon, Lisbon District, Portugal

Site Status

Hospital Universitario La Paz

Madrid, Madrid, Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Portugal Spain

Related Links

Access external resources that provide additional context or updates about the study.

http://www.idipaz.es/

Medical Research Institute

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2009-013398-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

HULP- Nefro 001

Identifier Type: -

Identifier Source: org_study_id