Trial document




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  DRKS00004343

Trial Description

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Title

Metabolomic studies in urine of kidney transplant patients

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Trial Acronym

Transplant-Metabolomics Study

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URL of the Trial

http://Keine

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Brief Summary in Lay Language

The study compares the concentrations of naturally-occuring substances in urine of patients at different times points after successful kidney transplantation. The aim is the identification of substances, which can be measured in urine and provide information on an impending organ rejection as early as possible.

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Brief Summary in Scientific Language

The study compares the concentrations of metabolic products (metabolites) in urine of patients at different time points after succesful kidney transplantation. Urine metabolites profiles will be characterized after succesful transplantation and profiles are compared between patients with biopsy-proven signs of organ rejection to those without such signs. The overarching aim is the identification of new biomarkers, which can be measured in urine and indicate an impending organ rejection as early as possible, ideally even before the function of the transplanted organ declines. Considering the enormous importance of succesful transplantations for patients with end-stage renal disease, the development of novel biomarkers is of very high clinical relevance.

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Organizational Data

  •   DRKS00004343
  •   2012/08/24
  •   [---]*
  •   yes
  •   Approved
  •   270/12, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   U1111-1133-7885 
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Health Condition or Problem studied

  •   Z94.0 -  Kidney transplant status
  •   T86.1 -  Kidney transplant failure and rejection
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Interventions/Observational Groups

  •   Observational group 1: urine collection in patients after kidney transplantation with signs/symptoms of organ rejection on kidney biopsy
  •   Observational group 2: urine collection in patients after kidney transplantation with signs/symptoms of organ rejection on kidney biopsy
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Diagnostic
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

The daily urine metabolite profile will be determined with NMR-spectroscopy in patients after kidney transplantation as long as they are inpatients on the surgical intensive care unit number 5.

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Secondary Outcome

Histopathologic examinations of bioptic transplant organ material, routinely performed three months after transplantation or in some cases earlier if acute rejection is suspected. In addition, kidney function parameters (e.g. creatinine, urea, urine output) are measured daily after kidney transplantation during the inpatient stay on the surgical intensive care unit 5.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2012/08/24
  •   200
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   70   Years
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Additional Inclusion Criteria

Participants aged 18 to 70 years, who recently underwent a succesfull kidney transplant at the university hospital Freiburg and are hospitalized at the surgical intensive care unit number five.

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Exclusion Criteria

Patients after recent unsuccesful transplantation or simultanous transplantion of another solid organ are excluded. In addition, patients who are unable to make informed decision and non-caucasian patient are excluded.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Emmy Noether Programm der Deutschen Forschungsgemeinschaft
    • Ms.  Privatdozentin Dr. med.  Anna  Köttgen 
    • Berliner Allee 29
    • 79110  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg, Innere Medizin IV
    • Mr.  Dr. med.  Ömer-Necmi  Gök 
    • Berliner Allee 29
    • 79110  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg, Innere Medizin IV
    • Mr.  Dr. med.  Ömer-Necmi  Gök 
    • Berliner Allee 29
    • 79110  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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    • Universitätsklinikum Freiburg
    • Hugstetter Strasse 49
    • 79095  Freiburg
    • Germany
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Status

  •   Recruiting withdrawn before recruiting started
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.