Precision Medicine Approaches to Renal Osteodystrophy (NCT05880914) | Clinical Trial Compass
RecruitingNot Applicable
Precision Medicine Approaches to Renal Osteodystrophy
United States40 participantsStarted 2022-12-21
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
ā. Study participant has provided informed consent
ā. Age ā„ 18 years
ā. CKD Stages 3-5D regardless of kidney transplantation status
ā. CKD5D patients receiving maintenance hemodialysis for at least 3 months
ā. PTH, BSAP and CTX meets defined thresholds for low or high turnover ROD type or a Bone biopsy evidence of low or high turnover based
Exclusion criteria
ā. 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)
ā. Currently receiving investigational procedures/drugs from another study while participating in this study
ā. 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
What they're measuring
1
Correlation between miRNA panel to discriminate changes in bone turnover.
Timeframe: Five years
2
Correlation between a miRNA panel that identifies bone turnover type is able to also identify with bone quality.
ā. New use of cinacalcet over the prior 6 months
ā. Use of Zoledronic Acid (Reclast) less than 24 months from study enrollment for patients with eGFR \<30mL/minute
ā. Anticipated or scheduled kidney transplant during the study period or less than 1 year from receiving a kidney transplant
ā. For patients with a solid organ transplant, less than 1 year from receiving the transplant
ā. Patient has an unstable medical condition based on medical history, physical examination, and routine laboratory tests, or is otherwise unstable in the judgment of the Investigator