An Observational Study to Assess the Effect of Calcineurin Inhibitors on Markers of Transplant Tolerance (OSCITT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by University Medical Center Goettingen.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Armin Goralczyk, University Medical Center Goettingen
ClinicalTrials.gov Identifier:
NCT01065584
First received: February 8, 2010
Last updated: September 14, 2011
Last verified: September 2011

February 8, 2010
September 14, 2011
February 2010
February 2012   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01065584 on ClinicalTrials.gov Archive Site
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An Observational Study to Assess the Effect of Calcineurin Inhibitors on Markers of Transplant Tolerance
An Observational Study to Assess the Effect of Calcineurin Inhibitors on Markers of Transplant Tolerance

In experimental and clinical settings it has been shown that transplant tolerance is possible. It has been suggested that regulatory T cells play a beneficial role in the establishment of tolerance. Calcineurin inhibitors may inhibit development of regulatory T cells. However, the influence of calcineurin inhibitors on markers of transplant tolerance has not been studied in patients undergoing liver transplantation. Currently the investigators conduct a study to evaluate the safety and efficacy of a calcineurin inhibitor free immunosuppression in patients undergoing liver transplantation. In this study measurements of immune function and CD4+CD25high-Foxp3+-Il2/CD8+ status will also be performed. In parallel these measurements should be compared to a group of patients undergoing standard immunosuppression including calcineurin inhibitors.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Blood cells for fluorescence activated cell sorting and leukocytes for ImmuKnow/Cylex assay

Non-Probability Sample

Patients undergoing liver transplantation

Liver Transplantation
Not Provided
  • Standard immunosuppression
    Patients receiving standard immunosuppression after liver transplantation including calcineurininhibitors
  • Immunosuppression without calcineurininhibitors
    Patients receiving immunosuppression after liver transplantation not based on calcineurininhibitors
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
58
April 2012
February 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients undergoing primary liver transplantation
  • Patients of age 18 years and older
  • Female patients of childbearing potential willing to perform a highly effective contraception during the study and 12 weeks after conclusion of study participation

Exclusion Criteria:

  • Multiple organ graft recipients
  • Patients receiving ABO incompatible grafts
  • Patients with positive cross match
  • Pregnancy
  • Patients with a psychological, familial, sociologic or geographic condition potentially hampering compliance with the study protocol and follow-up schedule
  • Patients under guardianship (e.g. individuals who are not able to freely give their informed consent)
Both
18 Years and older
No
Contact: Aiman Obed, Prof. Dr. +49 551 3912296 aobed@chirurgie-goettingen.de
Contact: Armin D Goralczyk, Dr. +49 551 3914638 agoralczyk@med.uni-goettingen.de
Germany
 
NCT01065584
OSCITT10
Yes
Armin Goralczyk, University Medical Center Goettingen
University Medical Center Goettingen
Not Provided
Study Chair: Aiman Obed, Prof. Dr. University Medical Center Goettingen
Principal Investigator: Armin Goralczyk, Dr. University Medical Center Goettingen
University Medical Center Goettingen
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP