Blood test strategy may spare kidney patients from unnecessary biopsies

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. All men and women, age ≥18 years old. 2. Subject must be a recipient of a single renal transplant from a deceased or living donor. 3. Subject is willing and able to provide signed written informed consent and willing to comply with study procedures 4. Women of Childbearing Potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study in such a manner that the risk of pregnancy is minimized. WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal \[defined as amenorrhea ≥ 12 consecutive months; or women on hormone replacement therapy (HRT) with documented serum follicle stimulating hormone (FSH) level \> 35 mIU/mL\]. WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of clinical trial Exclusion Criteria: 1. Subject with Hepatitis B chronic infection and/or active infection by Hepatitis C virus (positive blood PCR result at the moment of transplant). 2. Subjects with known human immunodeficiency virus (HIV) infection. 3. Patients with active systemic infection that requires the continued use of antibiotics. 4. Patients with neoplasia except localized skin cancer receiving appropriate treatment. 5. WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period, women who are pregnant or breastfeeding or women with a positive pregnancy test on enrolment. 6. Subjects who are legally detained in an official institution. 7. Primary non-function or early graft loss due to mechanical/surgical complications. 8. Death within the first 6 months after transplantation. 9. Any condition that, in the opinion of the investigator, might interfere with the patient's participation in the study, poses an added risk for the patient, or confounds the assessment of the patient 10. History of multi-organ transplant (interference with rejection natural history).