Trial document




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  DRKS00007693

Trial Description

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Title

Conditioning of immunosuppressive effects in renal transplant patients

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

In this study we investigate wether it is possible to condition an immunsuppresion in renal transplant patients. In rodents and healthy male test subjects a successfull conditioniing has already been shown. In this study we investigate wether a placebo intace in combination with a novel tasting drink can support the immunsuppression and prevent a decrease of the immunsuppression inbetween the drug intake in renal transplant patients, that take an immunosuppressive drug on a daily basis.
Therefore the patients drink the novel tasting drink as a conditioned stimulus simultaneously with the intake of their immunosuppressive drug. This paring takes place six times. After 7 days the drink is given with a placebo between the intake of the immunosuppressive drug in the morning and evening. It is expected, that the decrease of the suppressive effect, which arises after the intake of the immunosuppressive drug, is reduced.

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Brief Summary in Scientific Language

In this study we investigate wether it is possible to condition an immunsuppresion in renal transplant patients. In rodents and healthy male test subjects a successfull conditioniing has already been shown. In this study we investigate wether a placebo intace in combination with a novel tasting drink can support the immunsuppression and prevent a decrease of the immunsuppression inbetween the drug intake in renal transplant patients, that take the immunosuppressive drug Cyclosporin A or Tacrolimus on a daily basis.
Therefore the patients drink the novel tasting drink as a conditioned stimulus simultaneously with the intake of their immunosuppressive drug. This paring takes place six times in the acquisition phase. After 7 days the drink is given with a placebo between the intake of the immunosuppressive drug in the morning and evening. It is expected, that the decrease of the suppressive effect, which arises after the intake of the immunosuppressive drug, is reduced.

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Organizational Data

  •   DRKS00007693
  •   2015/03/02
  •   [---]*
  •   yes
  •   Approved
  •   13-5572-BO, Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen
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Secondary IDs

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Health Condition or Problem studied

  •   Z94.0 -  Kidney transplant status
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Interventions/Observational Groups

  •   novel drink in addition to immunosuppressive drug intake in the morning in the evening on three days; drink and placebo capsules between the immunosuppressive drug intake in the morning and the evening on two days
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Basic research/physiological study
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Analysis of the Interleukin-2- and the Interferon-Gamma-level and the proliferation of the t-cells 2, 6, and 10 hours after the immunosuppressive drug intake in the morning: On day 1 (Baseline), on which the conditioned stimulus has not been added yet, and on day 8, on which the conditioned stimulus is ingested together with placebo capsules 4 and 8 hours after the immunosuppressive drug intake in the morning.

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Secondary Outcome

On day 1 and 8 we analyse the subpopulation of the peripheral blood mononuclear cells, the cortisol- and the catecholamine-level 2, 6 and 10 hours after the immunosuppressive drug intake in the morning. The blood pressure will also be measured.
Additionaly the probands give information about side effects and psychological parameters via standardized questionnaires about one week before and in the morning and evening on study-days 1-3, 8-10 and 15-17.
Following questionnaires were used:
SSAS, HADS, BIS/BAS, BMQ, PSQ, Adherence Scale Marburg, STAI-State, STAI-Trait, SWE, SFA-K, GASE-P, SES-17. Furthermore we asked for general frequency of side effects, estimation of probability of side effects and occurrence of specific side effects. We also asked for a estimation of the beverage concerning different dimensions.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/04/13
  •   30
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

stable renal transplant patients, at least 1 year after transplantation, stable function of the transplant, ability to understand the aims of the study and for informed consent, immunosuppressive therapy including a calcineurin inhibitor, lymphocytes depletion drug in the last 12 months

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Exclusion Criteria

minority, pregnancy, malignoma, active rejection, chronic infectious disease (HIV, hep A+B+C), BK-nephropathy, acute infectious disease at the time of inclusion

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Addresses

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    • Universitätsklinikum Essen
    • Mr.  Prof. Dr. med.  Oliver  Witzke 
    • Hufelandstr. 55
    • 45122  Essen
    • Germany
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    • Institut für Medizinische Psychologie
    • Mr.  Professor Dr. rer. biol. hum.  Manfred  Schedlowski 
    • Hufelandstr.55
    • 45147  Essen
    • Germany
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    • Institut für Medizinische Psychologie
    • Ms.  M.Sc.  Anna Lena  Kahl 
    • Hufelandstr. 55
    • 45147  Essen
    • 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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Status

  •   Recruiting complete, follow-up complete
  •   2017/03/27
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Trial Publications, Results and other Documents

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