Conditioning of immunosuppressive effects in renal transplant patients

• Register: German Clinical Trials Register
• Last refreshed on: 8 April 2024
• Main ID: DRKS00007693
• Date of registration: 02/03/2015
• Prospective Registration: Yes
• Primary sponsor: Universitätsklinikum Essen
• Public title: Conditioning of immunosuppressive effects in renal transplant patients
• Scientific title: Conditioning of immunosuppressive effects in renal transplant patients
• Date of first enrolment: 13/04/2015
• Target sample size: 30
• Recruitment status: Complete
• URL: http://drks.de/search/en/trial/DRKS00007693
• Study type: interventional
• Study design: Allocation: N/A: single arm study; Masking: Open (masking not used); Control: uncontrolled; Assignment: single; Study design purpose: basic science
• Phase: N/A

Countries of recruitment

Germany

Contacts

• Name: Anna Lena Friedel
• Affiliation: Institut für Medizinische Psychologie

• Name: Manfred Schedlowski
• Affiliation: Institut für Medizinische Psychologie

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

Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Z94.0

Kidney transplant status

Z94.0

Intervention(s)

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

Primary Outcome(s)

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(s)

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.

Source(s) of Monetary Support

Deutsche Forschungsgemeinschaft

Ethics review

Status: Approved
Approval date: 14/01/2014
Contact:

[e-mail]

Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen

[phone]

[e-mail]

Results

• Results available: Yes
• Date Posted: 27/04/2018
• Date Completed: 27/03/2017
• URL: http://drks.de/search/en/trial/DRKS00007693#studyResults