Conditioning of immunosuppressive effects in renal transplant patients

Not Applicable

• Conditions: Z94.0; Kidney transplant status

• Registration Number: DRKS00007693
• Lead Sponsor: niversitätsklinikum Essen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-02
• Study Completion: 2017-03-27
• Results First Posted: 2018-04-02
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 30

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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. <br>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. <br>Following questionnaires were used:<br>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.