Reference Group Trial for The ONE Study

NCT01656135 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2016-03-09

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01656135 on ClinicalTrials.gov