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

This study is currently recruiting participants.
Verified September 2011 by University Medical Center Goettingen
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
History of Changes
  Purpose

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.


Condition
Liver Transplantation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Study to Assess the Effect of Calcineurin Inhibitors on Markers of Transplant Tolerance

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Medical Center Goettingen:

Biospecimen Retention:   Samples Without DNA

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


Estimated Enrollment: 58
Study Start Date: February 2010
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Standard immunosuppression
Patients receiving standard immunosuppression after liver transplantation including calcineurininhibitors
Immunosuppression without calcineurininhibitors
Patients receiving immunosuppression after liver transplantation not based on calcineurininhibitors

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients undergoing liver transplantation

Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01065584

Contacts
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

Locations
Germany
University Medical Center Goettingen Recruiting
Goettingen, Niedersachsen, Germany, 37099
Contact: Armin D Goralczyk, Dr.     +49 551 3914638     agoralczyk@med.uni-goettingen.de    
Contact: Aiman Obed, Prof. Dr.     +49 551 39 12296     aobed@chirurgie-goettingen.de    
Principal Investigator: Armin Goralczyk, Dr.            
Sub-Investigator: Aiman Obed, Prof. Dr.            
Sponsors and Collaborators
University Medical Center Goettingen
Investigators
Study Chair: Aiman Obed, Prof. Dr. University Medical Center Goettingen
Principal Investigator: Armin Goralczyk, Dr. University Medical Center Goettingen
  More Information

No publications provided

Responsible Party: Armin Goralczyk, Dr., University Medical Center Goettingen
ClinicalTrials.gov Identifier: NCT01065584     History of Changes
Other Study ID Numbers: OSCITT10
Study First Received: February 8, 2010
Last Updated: September 14, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Medical Center Goettingen:
liver transplantation
Patients undergoing liver transplantation

ClinicalTrials.gov processed this record on May 23, 2013