Z94.0
Conditions
Interventions
Group 1: 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
Sponsors
Universitätsklinikum Essen
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Germany
Contacts
Public ContactAnna Lena Friedel
Institut für Medizinische Psychologie
Outcome results
None listed