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Recruitment status Completed
Unique ID issued by UMIN UMIN000007864
Receipt No. R000009266
Scientific Title Evaluation of the effect of single-shot high dosed antithrombin in deceased donor kidney transplantation on ischemia/reperfusion injury and safety in a single center controlled randomized trial
Date of disclosure of the study information 2012/04/30
Last modified on 2012/04/30

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Basic information
Public title Evaluation of the effect of single-shot high dosed antithrombin in deceased donor kidney transplantation on ischemia/reperfusion injury and safety in a single center controlled randomized trial
Acronym Antithrombin in kidney transplantation
Scientific Title Evaluation of the effect of single-shot high dosed antithrombin in deceased donor kidney transplantation on ischemia/reperfusion injury and safety in a single center controlled randomized trial
Scientific Title:Acronym Antithrombin in kidney transplantation
Region
Europe

Condition
Condition End-stage renal failure
Classification by specialty
Nephrology Surgery in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the hypothesis that intraoperative high-dose AT administration can reduce I/R-injury in clinical deceased-donor kidney transplantation and can be applied safely in the clinical setting
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes primary efficacy variable: degree of graft I/R-injury
Key secondary outcomes secondary efficacy variable: transplant kidney function; tertiary efficacy variable:12-month graft/patient survival; safety variables relevant to intraoperative AT usage.: incidence of systemic anaphylaxis, incidence of bleeding events, number of units of packed red blood cells administered up to postoperative day 3, incidence of wound complications, and re-operations.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 treatment group: intraoperative administration via central venous line of a single-dose of 4,000 IU of AT (Atenativ, Octapharma, Langenfeld, Germany) at the beginning of the renal vein anastomosis, AT administration completeted by the time of reperfusion.
Interventions/Control_2 control group: corresponding dose of human albumin
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria informed consent, age >18 years, undergoing deceased donor kidney transplantation
Key exclusion criteria ongoing medication with anticoagulant drugs with the exception of acetylsalicylic acid, positive history of bleeding/procoagulant disorders (hereditary AT-deficiency, factor-V-Leiden mutation, prothrombin mutation, antiphospholipid syndromes, deficiency of protein C or protein&#160;S)
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Johannes N. Hoffmann, MD
Organization Ludwig-Maximilians-University Munich, Germany
Division name Campus Grosshadern, Dpt. of surgery
Zip code
Address Marchioninistr. 15, 81377 Munich, Germany
TEL 498970950
Email

Public contact
Name of contact person
1st name
Middle name
Last name Jan M. Fertmann, MD
Organization Ludwig-Maximilians-University Munich, Germany
Division name Campus Grosshadern, Dpt. of surgery
Zip code
Address Marchioninistr. 15, 81377 Munich, Germany
TEL 498970950
Homepage URL http://www.klinikum.uni-muenchen.de/Chirurgische-Klinik-und-Poliklinik-Grosshadern/de/index.html
Email jan.fertmann@med.uni-muenchen.de

Sponsor
Institute Ludwig-Maximilians-University Munich, Germany
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Study is in part funded by Octapharma (Langenfeld, Germany)
Organization
Division
Category of Funding Organization Outside Japan
Nationality of Funding Organization Germany

Other related organizations
Co-sponsor none
Name of secondary funder(s) none

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions University Hospital of Ludwig-Maximilians-University, Campus Grosshadern, Munich, Germany

Other administrative information
Date of disclosure of the study information
2012 Year 04 Month 30 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2001 Year 06 Month 15 Day
Date of IRB
Anticipated trial start date
2001 Year 09 Month 01 Day
Last follow-up date
2004 Year 04 Month 01 Day
Date of closure to data entry
2005 Year 08 Month 01 Day
Date trial data considered complete
2005 Year 08 Month 01 Day
Date analysis concluded
2006 Year 02 Month 01 Day

Other
Other related information

Management information
Registered date
2012 Year 04 Month 30 Day
Last modified on
2012 Year 04 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009266


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