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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2011 by Armin Goralczyk, University Medical Center Goettingen.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01065584
First Posted: February 9, 2010
Last Update Posted: September 15, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Armin Goralczyk, University Medical Center Goettingen
  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:


Further study details as provided by Armin Goralczyk, 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Armin Goralczyk, Dr., University Medical Center Goettingen
ClinicalTrials.gov Identifier: NCT01065584     History of Changes
Other Study ID Numbers: OSCITT10
First Submitted: February 8, 2010
First Posted: February 9, 2010
Last Update Posted: September 15, 2011
Last Verified: September 2011

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

Additional relevant MeSH terms:
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action