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CompletedNCT01656135

Reference Group Trial for The ONE Study

Reference Group Trial for The ONE Study: A Unified Approach to Evaluating Cellular Immunotherapy in Solid Organ Transplantation

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
70 (actual)
Sponsor
University of Regensburg · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

To investigate the progression of the immunological response in living-donor kidney transplant recipients treated with a standard immunosuppressive regimen. Clinical, immunological, and health-economic data collected during this Reference Group Trial will be used to corroborate historical renal transplantation statistics and generate reference ranges for future clinical studies that will test immunoregulatory cell therapy as an adjunct immunosuppressive treatment in renal transplantation.

Conditions

Interventions

TypeNameDescription
OTHERBlood drawing for immune monitoring and questionnaires

Timeline

Start date
2012-12-01
Primary completion
2015-12-01
Completion
2015-12-01
First posted
2012-08-02
Last updated
2016-03-09

Locations

8 sites across 5 countries: United States, France, Germany, Italy, United Kingdom

Source: ClinicalTrials.gov record NCT01656135. Inclusion in this directory is not an endorsement.

Reference Group Trial for The ONE Study (NCT01656135) · Clinical Trials Directory