An Observational Study to Assess the Effect of Calcineurin Inhibitors on Markers of Transplant Tolerance
OSCITT
1 other identifier
observational
58
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2010
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 8, 2010
CompletedFirst Posted
Study publicly available on registry
February 9, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedSeptember 15, 2011
September 1, 2011
2 years
February 8, 2010
September 14, 2011
Conditions
Keywords
Study Arms (2)
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 Criteria
Patients undergoing liver transplantation
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Medical Center Goettingen
Göttingen, Lower Saxony, 37099, Germany
Biospecimen
Blood cells for fluorescence activated cell sorting and leukocytes for ImmuKnow/Cylex assay
Study Officials
- STUDY CHAIR
Aiman Obed, Prof. Dr.
University Medical Center Goettingen
- PRINCIPAL INVESTIGATOR
Armin Goralczyk, Dr.
University Medical Center Goettingen
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
February 8, 2010
First Posted
February 9, 2010
Study Start
February 1, 2010
Primary Completion
February 1, 2012
Study Completion
April 1, 2012
Last Updated
September 15, 2011
Record last verified: 2011-09