A Study to Evaluate Kidney Care and HistoMap in Microvascular Inflammation
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Scottsdale/Phoenix, Arizona: 21-005199
About this study
The purpose of this study is to evaluate KidneyCare (AlloSure, AlloMap kidney and iBox) in patients with negative c4d microvascular inflammation (MVI) with or without Donor-Specific Antibodies (DSA) as compared to cohort with normal biopsies without DSA.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Participant is willing and able to give informed consent for participation in the study.
- Male or female, aged 18 years or above.
- Solitary kidney transplant recipients undergoing protocol biopsy at 4 months or 1 year or for cause biopsy.
- HistoMap: biopsy findings of microvascular inflammation defined g> 0 + pts>0 > 2 with negative c4d with or without DSA.
Exclusion Criteria:
- Subjects < 18 years of age.
- Multiorgan transplant recipients.
- ABO incompatible transplantation including A2 to B or O transplantation.
- Patients undergoing desensitization prior to transplantation.
- Previous history cell mediated or antibody mediated rejection or mixed rejection.
- BK or CMV infection.
- Any systemic infection besides UTI.
- Patients must not be receiving any other investigational agents.
- Pregnancy.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 6/03/2024. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Girish Mour, M.B.B.S. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available