Reference Group Trial for The ONE Study

Inclusion criteria

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.

Exclusion criteria

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
• The career, lifestyle, or sexual orientation of the patient ensures that there is no risk of pregnancy for the duration of the study (at the discretion of the local Investigator)
• Psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow-up visit schedule
• 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
• Patients unable to freely give their informed consent (e.g. individuals under legal guardianship).