Paired Marrow Aspirations to Assess Assays in Sensitized Renal Allograft Recipients
Overview
Tab Title Description
Study type
InterventionalDescribes 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
- Rochester, Minnesota: 10-002572
NCT ID: NCT01150487
Sponsor Protocol Number: 10-002572
About this study
The aim of this study is to determine the validity of two tests on bone marrow of sensitized kidney transplant recipients in order to better understand why these patients with antibodies against their donors are at a greater risk of rejection of their transplanted organs.
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:
- Pre or post renal transplant recipients who are "sensitized", having allo antibodies
as evidenced by single antigen bead analysis).
- Renal transplant donors.
- Those who give voluntary written informed consent before performance of any
study-related procedures, which are not part of normal medical care, with the
understanding that consent may be withdrawn by the subject at any time without
prejudice to future medical care.
Exclusion Criteria:
- Any patient currently receiving systemic anticoagulation therapy with heparin or
coumadin.
- Patient has a platelet count of < 30 x 10^9/L within 14 days before enrollment.
- Patient has an absolute neutrophil count of ANC < 1.0 x 10^9/L within 14 days before
enrollment.
- Patient has received other investigational drugs within14 days before enrollment.
- Serious medical or psychiatric illness likely to interfere with participation in this
clinical study.
- Diagnosed or treated for malignancy within 5 years of enrollment, with the exception
of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin,
an in situ malignancy, or low-risk prostate cancer after curative therapy.
- Contraindication to kidney transplantation or donation-active infection, comorbid
medical conditions, etc
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 |
|
Rochester, Minn.
Mayo Clinic principal investigator Mark Stegall, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available