Reference Group Trial for The ONE Study

Completed · Phase 4

Conditions studied: End-stage Renal Failure, Kidney Graft Rejection

In brief

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.

Key facts

Study ID

NCT01656135

Run by

University of Regensburg

People needed

70

Starts

2012-12-01

Expected to finish

2015-12-01

Last updated by the study team

2016-03-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Organ Donor:
• A prospective donor is eligible for the research if all of the following inclusion criteria apply:
• 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.
• In signing the donor information sheet/informed consent form (DIS/ICF), organ donors agree to provide a blood sample for the IM Subproject, and permit access to their medical records for the collection of specified demographic and medical/biological data for the trial.
• Organ Recipient:
• Chronic renal insufficiency necessitating kidney transplantation and approved to receive a primary kidney allograft from a living donor
• Aged at least 18 years
• Able to commence the immunosuppressive regimen at the protocol-specified time point
• Willing and able to participate in The ONE Study subprojects
• Signed and dated written informed consent.

You may not qualify if…

• Organ Donor:
• If a prospective donor fulfils any of the following criteria, then they are ineligible for the trial:
• 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).
• Organ Recipient:
• Patient has previously received, or is scheduled to receive, any tissue or organ transplant other than the planned kidney graft
• Known sensitivity to tacrolimus, mycophenolate, or corticosteroids
• Genetically identical to the prospective organ donor at the HLA loci
• PRA grade > 40% within 6 months prior to enrolment
• Previous treatment with any desensitisation procedure (with or without IVIg)
• Concomitant malignancy or history of malignancy within 5 years prior to planned study entry (excluding successfully-treated non-metastatic basal/squamous cell carcinoma of the skin)
• Evidence of significant local or systemic infection
• HIV-positive, EBV-negative or suffering chronic viral hepatitis
• Significant liver disease, defined as persistently elevated AST and/or ALT levels >2 x ULN (Upper Limit of Normal range)
• Malignant or pre-malignant haematological conditions
• Any uncontrolled medical condition or concurrent disease that could interfere with the study objectives
• Any condition which, in the judgement of the Investigator, would place the subject at undue risk
• Ongoing treatment with systemic immunosuppressive drugs at study entry
• Participation in another clinical trial during the study or within 28 days prior to planned study entry
• Female patients of child-bearing potential with a positive pregnancy test at enrolment
• Female patients who are breast-feeding
• All female patients of child-bearing potential UNLESS:
• The patient is willing to maintain a highly effective method of birth control for the duration of the study

Where it is running

• University of California San Francisco — San Francisco, California, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• CHU de Nantes Hotel-Dieu — Nantes, France
• Charite Campus Virchow-Klinikum — Berlin, Germany
• University Hospital Regensburg — Regensburg, Germany
• Ospedale San Raffaele — Milan, Italy
• Guy's Hospital in affiliation with King's College London — London, United Kingdom
• Churchill Hospital in affiliation with the University of Oxford — Oxford, United Kingdom

Full record on ClinicalTrials.gov

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