Liver TransplantationOSCITTNCT01065584
An Observational Study to Assess the Effect of Calcineurin Inhibitors on Markers of Transplant Tolerance
An observational study of Liver Transplantation, run by University Medical Center Goettingen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplantation
- How many people
- 58 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2010to Apr 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing liver transplantation
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Medical Center Goettingen
Göttingen, Lower Saxony, 37099
Armin D Goralczyk, Dr., +49 551 3914638, agoralczyk@med.uni-goettingen.de
Aiman Obed, Prof. Dr., +49 551 39 12296, aobed@chirurgie-goettingen.de
About this study
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.
- Conditions
- Liver Transplantation
- Keywords
- liver transplantation, Patients undergoing liver transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Standard immunosuppression | Patients receiving standard immunosuppression after liver transplantation including calcineurininhibitors | |
| Immunosuppression without calcineurininhibitors | Patients receiving immunosuppression after liver transplantation not based on calcineurininhibitors |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionFeb 2012 (estimated)
- Study completionApr 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Goettingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Armin Goralczyk, University Medical Center Goettingen
- Investigators
- Aiman Obed, Prof. Dr., Study chair, University Medical Center GoettingenArmin Goralczyk, Dr., Principal investigator, University Medical Center Goettingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01065584
- Sponsor's protocol ID
- OSCITT10
- Acronym
- OSCITT
- Status last verified
- Sep 2011
- First submitted
- 8 Feb 2010
- Last updated
- 15 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study to Assess the Effect of Calcineurin Inhibitors on Markers of Transplant Tolerance
- ClinicalTrials.gov ID
- NCT01065584
- Acronym / sponsor ID
- OSCITT / OSCITT10
- Conditions
- Liver Transplantation
- Keywords
- liver transplantation, Patients undergoing liver transplantation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- University Medical Center GoettingenUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Feb 2012 (estimated)
- Study completion
- Apr 2012 (estimated)
- First posted
- 9 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard immunosuppression | – | –Patients receiving standard immunosuppression after liver transplantation including calcineurininhibitors |
| Immunosuppression without calcineurininhibitors | – | –Patients receiving immunosuppression after liver transplantation not based on calcineurininhibitors |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing liver transplantation
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aiman Obed, Prof. Dr. study chair
University Medical Center Goettingen
Armin Goralczyk, Dr. principal investigator
University Medical Center Goettingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplantation, run by University Medical Center Goettingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aiman Obed, Prof. Dr. (+49 551 3912296, aobed@chirurgie-goettingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2011.