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Bone Marrow Aspiration for Kidney Transplant Rejection

N/A
Recruiting
Led By Mark Stegall, MD
Research Sponsored by Mark Stegall
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Pre or post renal transplant recipients who are 'sensitized', having allo antibodies as evidenced by single antigen bead analysis
Be older than 18 years old
Must not have
Any patient currently receiving systemic anticoagulation therapy with heparin or coumadin
Contraindication to kidney transplantation or donation-active infection, comorbid medical conditions, etc
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether two different tests can show why patients who have had a kidney transplant and have developed antibodies against their donor are at a greater risk for their transplanted organ being rejected.

Who is the study for?
This trial is for kidney transplant recipients with antibodies against their donors (sensitized) and the living donors themselves. Participants must consent to study procedures not part of normal care. Excluded are those with low neutrophil or platelet counts, recent investigational drug use, current systemic anticoagulation therapy, certain cancer histories within 5 years, or serious medical/psychiatric conditions.
What is being tested?
The study tests the validity of two assays on bone marrow from sensitized kidney transplant recipients to understand the higher rejection risk in these patients. It involves marrow aspirations from both recipients and living donors to assess immune responses.
What are the potential side effects?
While specific side effects are not listed for bone marrow aspirations in this summary, common ones include pain at the aspiration site, bleeding, bruising, and infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have antibodies against a kidney transplant as shown by a specific test.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am currently on blood thinners like heparin or coumadin.
Select...
I cannot have a kidney transplant due to an infection or other health issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Kidney recipients or kidney donorsExperimental Treatment2 Interventions
Patients who have had a Kidney transplant or are undergoing a kidney transplant. Kidney donors.

Find a Location

Who is running the clinical trial?

Mark StegallLead Sponsor
3 Previous Clinical Trials
1,235 Total Patients Enrolled
Mayo ClinicLead Sponsor
3,362 Previous Clinical Trials
3,065,461 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,336 Previous Clinical Trials
5,382,334 Total Patients Enrolled
Mark Stegall, MDPrincipal Investigator - Mayo Clinic
Mayo Clinic Hospital-Rochester Saint Marys Campus
Columbia University College Of Physicians And Surgeons (Medical School)
University Of Wi Hosp & Cli (Residency)
4 Previous Clinical Trials
310 Total Patients Enrolled

Media Library

bone marrow aspirations Clinical Trial Eligibility Overview. Trial Name: NCT01150487 — N/A
Kidney Transplant Recipients Research Study Groups: Kidney recipients or kidney donors
Kidney Transplant Recipients Clinical Trial 2023: bone marrow aspirations Highlights & Side Effects. Trial Name: NCT01150487 — N/A
bone marrow aspirations 2023 Treatment Timeline for Medical Study. Trial Name: NCT01150487 — N/A
~135 spots leftby Apr 2030
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