Paired Marrow Aspirations to Assess Assays in Sensitized Renal Allograft Recipients
Study type: Observational What is this?
Describes 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.
- 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.
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. If you need assistance understanding the eligibility criteria, please contact the study team.
See eligibility criteria
- Pre or post renal transplant recipients who are "sensitized", having allo antibodies as evidenced by single antigen bead analysis (mean fluorescence index, MFI >1000).
- 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of any study-related procedures, which are not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
- Any patient currently receiving systemic anticoagulation therapy with heparin or Coumadin.
- Patient has a platelet count of <30x 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 within 14 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—active infection, comorbid medical conditions, etc.
Participating Mayo Clinic locations
Study statuses change often. Please contact us for help.