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A Study to Evaluate Kidney Care and HistoMap in Microvascular Inflammation

Overview

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 Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Girish Mour, M.B.B.S.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Allyson Fultz

(480) 574-2272

Fultz.Allyson@mayo.edu

More information

Publications

Publications are currently not available

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