Condition category
Nutritional, Metabolic, Endocrine
Date applied
14/03/2006
Date assigned
12/04/2006
Last edited
04/11/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.meduniwien.ac.at/nephrogene

Contact information

Type

Scientific

Primary contact

Prof Rainer Oberbauer

ORCID ID

Contact details

Vienna Medical University
Waehringer Gürtel 18-20
Vienna
1090
Austria
+43 (0)140 400 4358
rainer.oberbauer@meduniwien.ac.at

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

P-18325

Study information

Scientific title

Acronym

Study hypothesis

Deceased organ donors exhibit a severe systemic inflammatory response caused by the brain death syndrome. This leads to an activation of inflammatory regulators in the donor kidney, associated with increased risk for subsequent development of post-ischemic acute renal transplant failure (ARTF) in the recipient. ARTF is the main risk factor for shortened allograft survival. Pre-treatment of deceased organ donors with corticosteroids before organ retrieval may modify the genome-wide gene expression in the donor kidney and thus reduce the incidence and duration of post-ischemic ARTF after engraftment.

Ethics approval

Approved by the Ethics Committee of the Medical University Vienna on 14/03/2005, reference number: 067/2005

Study design

Randomised placebo-controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

Condition

Pre-treatment of deceased organ donors

Intervention

The deceased organ donor will be randomized to receive 1000 mg of methylprednisolone or placebo three to six hours before organ retrieval. Donor kidney biopsies will be obtained before engraftment and genome-wide gene expression analysis will be performed using complementary deoxyribonucleic acid (cDNA) microarrays.

Intervention type

Drug

Phase

Not Specified

Drug names

Methylprednisolone

Primary outcome measures

Incidence and duration of post-ischemic acute renal transplant failure in the transplant recipient

Secondary outcome measures

Genome-wide gene expression analysis of transplant kidney wedge biopsies

Overall trial start date

20/03/2006

Overall trial end date

20/09/2008

Reason abandoned

Eligibility

Participant inclusion criteria

Deceased kidney donors

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200 deceased organ donors

Participant exclusion criteria

Non-heart beating organ donors

Recruitment start date

20/03/2006

Recruitment end date

20/09/2008

Locations

Countries of recruitment

Austria

Trial participating centre

Vienna Medical University
Vienna
1090
Austria

Sponsor information

Organisation

Austrian Science Fund

Sponsor details

Weyringergasse 35
Vienna
1040
Austria
+43 (0)1 505 67 40
office@fwf.ac.at

Sponsor type

Government

Website

http://www.fwf.ac.at

Funders

Funder type

Government

Funder name

Austrian Science Funds (grant P-18325)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20713790

Publication citations

  1. Results

    Kainz A, Wilflingseder J, Mitterbauer C, Haller M, Burghuber C, Perco P, Langer RM, Heinze G, Oberbauer R, Steroid pretreatment of organ donors to prevent postischemic renal allograft failure: a randomized, controlled trial., Ann. Intern. Med., 2010, 153, 4, 222-230, doi: 10.7326/0003-4819-153-4-201008170-00003.

Additional files

Editorial Notes