Inclusion Criteria:

• At least 18 years of age.
• Recipient of a kidney allograft transplant prior to enrollment.
• The kidney transplant may be conducted with or without another type of organ.
• The kidney transplant after which the subject is eligible for enrollment need not be the first kidney allograft.
• If previous kidney transplant was a preemptive and occurred ≤ six months from study enrollment, then the patient self-reported urine output at the time of the preemptive transplant needs to be ≤ two cups or 500 ml per day.
• The patient or the patient’s legally appointed representative has understood and signed the Informed Consent Form • The patient is at least 18 years of age • The patient has received a kidney or kidney plus another organ transplant prior to enrollment.
• Treatment for kidney allograft rejection and/or inflammation must have been completed at least six months prior to enrollment. Inflammation is defined as pathologic lymphoproliferative infiltrate, moderate to severe lymphocytic infiltration, interstitial nephritis (BKV nephritis or acute interstitial nephritis), glomerulopathy, and/or immune complex deposition.
• If subject is within 6 months of a pre-emptive kidney transplant the subject is eligible if at the time of transplant the self-reported urine output was ≤ 2 cups/day or ≤ 500 ml/day.
• The patient must be able and willing to follow-up with the study Investigator.
• The patient must be willing to undergo a biopsy procedure.
• The patient must be able and willing to donate the required number and volume of urine specimen(s) • The patient must be able and willing to complete the User Experience Questionnaire.

Exclusion Criteria:

• The patient or the patient’s legally appointed representative is unable or unwilling to sign the Informed Consent Form.
• The patient is not at least 18 years of age.
• If subject is within 6 months of a pre-emptive kidney transplant the subject is ineligible if at the time of transplant the self-reported urine output was > 2/day cups or > 500 ml/day.
• The patient has previously enrolled in this study.
• The patient is unwilling to provide the required urine specimen(s).
• The patient is unable or unwilling to complete the User Experience Questionnaire.
• Treatment for kidney allograft rejection and/or inflammation was not completed at least six months prior to enrollment. Inflammation is defined as pathologic lymphoproliferative infiltrate, moderate to severe lymphocytic infiltration, interstitial nephritis (BKV nephritis or acute interstitial nephritis), glomerulopathy, and/or immune complex deposition.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 1/8/24. Questions regarding updates should be directed to the study team contact.