Reference Group Trial for The ONE Study (NCT01656135) | Clinical Trial Compass
CompletedPhase 4
Reference Group Trial for The ONE Study
United States, France, Germany70 participantsStarted 2012-12
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Eligible for live kidney donation
✓. Aged at least 18 years
✓. An ABO blood type compatible with the organ recipient
✓. Willing and able to provide a blood sample for The ONE Study Subprojects
✓. Willing to provide personal and medical/biological data for the trial
✓. Signed and dated written informed consent.
✓. Chronic renal insufficiency necessitating kidney transplantation and approved to receive a primary kidney allograft from a living donor
✓. Aged at least 18 years
Exclusion criteria
✕. Genetically identical to the prospective organ recipient at the HLA loci
✕. Exposure to any investigational agents at the time of kidney donation, or within 28 days prior to kidney donation
✕. Any form of substance abuse, psychiatric disorder, or other condition that, in the opinion of the Investigator, may invalidate communication with the Investigator and/or designated study personnel
✕. Subjects unable to freely give their informed consent (e.g. individuals under legal guardianship).
✕. Patient has previously received, or is scheduled to receive, any tissue or organ transplant other than the planned kidney graft