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Conditioning of immunosuppressive effects in renal transplant patients

Organizational Data

DRKS-ID:
DRKS00007693
Recruitment Status:
Recruiting complete, study complete
Date of registration in DRKS:
2015-03-02
Last update in DRKS:
2023-08-04
Registration type:
Prospective

Acronym/abbreviation of the study

No Entry

URL of the study

No Entry

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.

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.

Health condition or problem studied

ICD10:
Z94.0 - Kidney transplant status
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 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

Endpoints

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.
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.

Study Design

Purpose:
Basic research/physiological study
Allocation:
N/A (single arm study)
Control:
  • Uncontrolled/single arm
Phase:
N/A
Study type:
Interventional
Mechanism of allocation concealment:
No Entry
Blinding:
No
Assignment:
Single (group)
Sequence generation:
No Entry
Who is blinded:
No Entry

Recruitment

Recruitment Status:
Recruiting complete, study complete
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Monocenter study
Recruitment location(s):
  • University medical center Essen

Recruitment period and number of participants

Planned study start date:
2015-04-13
Actual study start date:
2015-04-13
Planned study completion date:
No Entry
Actual Study Completion Date:
2017-03-27
Target Sample Size:
30
Final Sample Size:
30

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
70 Years
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

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

Addresses

Primary Sponsor

Universitätsklinikum Essen
Prof. Dr. med. Oliver Witzke
Hufelandstr. 55
45122 Essen
Germany
Telephone:
02017233394
Fax:
No Entry
Contact per E-Mail
URL:
http://www.uk-essen.de/nephrologie/
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Institut für Medizinische Psychologie
Professor Dr. rer. biol. hum. Manfred Schedlowski
Hufelandstr.55
45147 Essen
Germany
Telephone:
02017234500
Fax:
02017235948
Contact per E-Mail
URL:
http://www.uk-essen.de/medizinische-psychologie/

Contact for Public Queries

Institut für Medizinische Psychologie
M.Sc. Anna Lena Friedel
Hufelandstr. 55
45147 Essen
Germany
Telephone:
02017233975
Fax:
02017235948
Contact per E-Mail
URL:
http://www.uniklinikum-essen.de/medizinische-psychologie/

Principal Investigator

Institut für Medizinische Psychologie
Professor Dr. rer. biol. hum. Manfred Schedlowski
Hufelandstr.55
45147 Essen
Germany
Telephone:
02017234500
Fax:
02017235948
Contact per E-Mail
URL:
http://www.uk-essen.de/medizinische-psychologie/

Sources of Monetary or Material Support

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)

Deutsche Forschungsgemeinschaft
Kennedyallee 40
53175 Bonn
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
http://www.dfg.de

Ethics Committee

Address Ethics Committee

Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen
Robert-Koch-Str. 9-11
45147 Essen
Germany
Telephone:
+49-201-7233637
Fax:
+49-201-7235837
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2013-08-27
Ethics committee number:
13-5572-BO
Vote of the Ethics Committee:
Approved
Date of the vote:
2014-01-14

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
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Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
Kirchhof J, Petrakova L, Brinkhoff A, Benson S, Schmidt J, Unteroberdörster M, Wilde B, Kaptchuk TJ, Witzke O, Schedlowski M. Learned immunosuppressive placebo responses in renal transplant patients. Proc Natl Acad Sci U S A. 2018 Apr 17;115(16):4223-4227. doi: 10.1073/pnas.1720548115. Epub 2018 Apr 2. PMID: 29610294; PMCID: PMC5910853.
Date of first publication of study results:
2018-04-02
DRKS entry published for the first time with results:
2018-04-27

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry