Trial document





This trial has been registered retrospectively.
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  DRKS00006552

Trial Description

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Title

Investigation of the physical and psychosocial outcomes after living kidney donation - A multicentre cohort study (Safety of Living Kidney Donors)

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

The main aim of the study is to examine the physical and psychosocial outcomes of living kidney donors after the transplantation in an interdisciplinary approach (surgery / urology, internal medicine / nephrology, psychosocial medicine). Because in western countries the majority of the donators are of female gender (> 60%) and with increasing number of about 60-year of agethis group will become significant increasing. However, there is a lack of data to their specific risks which will be within the scope of the study for the first time.

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Brief Summary in Scientific Language

The study is carried out as a nationwide multicenter study. In a naturalistic design (cohort study) clinical data and self-information of the donor (questionnaires) will be collected before and 8 weeks, 6 and 12 months after the donation. All adult living kidney donors with sufficient German knowledge and place of residence in Germany will be included. Primary aim parameters are the kidney function (GFR) and the quality of life (SF-36) of the donor. Secondary aim parameters are other data about possible physical (e.g., sore healing, blood pressure) and psychosocial (depression, fear, somatization) outcomes after the donation.

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Organizational Data

  •   DRKS00006552
  •   2014/09/22
  •   [---]*
  •   yes
  •   Approved
  •   2013-587-f-S, Ethik-Kommission der Ärztekammer Westfalen-Lippe und der med. Fakultät der Westfälischen Wilhelms-Universität Münster
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Secondary IDs

  •   01GY1321  (Förderkennzeichen BMBF)
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Health Condition or Problem studied

  •   Risk of living kidney donation
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Interventions/Observational Groups

  •   Quality of life and psychosocial parameters like depression, fear and somatization in living kidney donors will be assessed by means of standardized questionnaires. Furthermore, routine clinical data of the donors and the kidney recipients before and after the surgery (e.g., blood values and urine values, body weight and body height, drug status, sore healing, blood pressure) will be collected.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Health care system
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Quality of life (SF-36) and kidney function (e-GFR) of the donors in the course of 12 months

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Secondary Outcome

Physical (e.g., high blood pressure) and psychosocial (e.g., depression, fear) outcomes after living kidney donation.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2014/05/14
  •   320
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

1. Living kidney donor before nephrectomy
2. written consent

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Exclusion Criteria

1. Not German residency
2. A lack of reading comprehensionof German, Turkish or Russian language.

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Addresses

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    • WWU Münster
    • Ms.  Prof.  Ursula  Nelles 
    • Schlossplatz 2
    • 48149  Münster
    • Germany
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    • Uniklinik Münster
    • Mr.  Prof.  Markus  Burgmer 
    • Domagkstr. 22
    • 48149  Münster
    • Germany
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    • Uniklinik Münster
    • Ms.  Dr. phil.  Viktoriya  Wörmann 
    • Domagkstr. 22
    • 48149  Münster
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Friedrichstraße 130 B
    • 10117  Berlin
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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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.