Thymoglobulin in Cadaver Donor

September 5, 2013 updated by: Instituto de Investigación Hospital Universitario La Paz

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Lisbon, Portugal, 1649-035
        • Hospital Santa Maria
  • Spain
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 days
Security of Thymoglobuline in cadaveric donor
Time Frame: 1 day
Estimated by general and particularly hemodynamic tolerance to thymoglobulin infusion.
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 moths
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.
1 month
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Investigación Hospital Universitario La Paz

Collaborators

Hospital de Santa Maria, Portugal

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

August 29, 2013

First Submitted That Met QC Criteria

September 5, 2013

First Posted (Estimate)

September 11, 2013

Study Record Updates

Last Update Posted (Estimate)

September 11, 2013

Last Update Submitted That Met QC Criteria

September 5, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HULP- Nefro 001
  • 2009-013398-16 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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