A Study of Study of Immune Tolerance Mechanisms in Kidney Transplant Patients

Overview

About this study

Hypothesis: we hypothesize that the abundance and functions of Breg subsets in kidney transplant patients could be associated with transplant tolerance and rejection, including DSA-mediated kidney transplant rejection. In addition, oral corticosteroid treatment significantly alters the frequency and function of Breg subsets, which could lead altered clinical outcomes.

Aims, purpose, or objectives:
1. Investigate the frequency Bregs and their ability to express IL-10 along with other immune cells in the context of tolerance/rejection in kidney transplant patients.
we hypothesize that the abundance and functions of Breg subsets in kidney transplant patients could be associated with transplant tolerance and rejection, including DSA-mediated kidney transplant rejection.

2.Investigate the frequency and functions of Bregs along with other immune cells in the setting of long term corticosteroid use.
We hypothesize that oral corticosteroid treatment significantly alters the frequency and function of Breg subsets, which could lead altered clinical outcomes.

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:

  • Subjects 18 – 64 years of age.
  • Subjects who weigh at least 110 pounds (50 kilograms).
  • Subjects who understand that participation is voluntary.
  • Subjects who are able to complete the informed consent process.

Exclusion Criteria: 

  • Subjects who are younger than 18 years of age.
  • Subjects who have a current acute viral, bacterial, or fungal infection.
  • Subjects diagnosed with the Human Immunodeficiency Virus (HIV), or who have tested positive for HIV documented by any licensed ELISA assay and confirmed by Western Blot procedures at any time prior to donation.
  • Pregnant women.
  • Simultaneous dual organ transplant.
  • ABO incompatible transplants.
  • Patients with evidence of recurrentprimary disease.
  • Ongoing BK nephropathy.

 

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

SangKon Oh, Ph.D.

Open for enrollment

Contact information:

April Howard B.S.N., R.N.

(480) 342-5756

Howard.April@mayo.edu

More information

Publications

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Study Results Summary

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Supplemental Study Information

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