Treatment of renal osteodystrophy is impeded by the lack of practical and accurate tools to determine underlying bone turnover. Gold standard bone biopsy is not practical in the clinic for the vast majority of kidney disease patients and parathyroid hormone and bone alkaline phosphatase have insufficient accuracy for turnover type to safely and confidently guide treatment of renal osteodystrophy. In the present investigation, the investigators will study a microRNA approach as a novel non-invasive biomarker of turnover for renal osteodystrophy.
Study participant has provided informed consent
Age ≥ 18 years
CKD Stages 3-5D regardless of kidney transplantation status
CKD5D patients receiving maintenance hemodialysis for at least 3 months
Currently receiving treatment in an investigational device or drug study, or less than 30 days since ending treatment on an investigational device or drug study(s)
Currently receiving investigational procedures/drugs from another study while participating in this study
Use of etelcalcetide, bisphosphonate, denosumab, teriparatide, abaloparatide or romosozumab during the 6 months prior to study enrollment; however, participant can be included if being treated with bone active agent but will have class change to an agent that will result in a change in bone turnover from low to high or high to low
New use of cinacalcet over the prior 6 months
Thomas Nickolas
Lead sponsor
Washington University School of Medicine
Sponsor institution
Indiana University
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator