Reference Group Trial for The ONE Study
NCT01656135 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 70
Last updated 2016-03-09
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
- End-stage Renal Failure
- Kidney Graft Rejection
Interventions
- OTHER
-
Blood drawing for immune monitoring and questionnaires
Sponsors & Collaborators
- collaborator OTHER
-
University of Regensburg
lead OTHER
Principal Investigators
-
Edward K. Geissler, Ph.D. · University of Regensburg
Study Design
- Allocation
- NA
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-12-31
- Primary Completion
- 2015-12-31
- Completion
- 2015-12-31
Countries
- United States
- France
- Germany
- Italy
- United Kingdom
Study Locations
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