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NCT05880914
Precision Medicine Approaches to Renal Osteodystrophy
Conditions: Renal Osteodystrophy, Chronic Kidney Diseases, CKD-MBD, Bone Turnover Rate Disorder, Secondary Hyperparathyroidism
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 40
Sponsor: Thomas Nickolas
Location: Washington University in St. Louis (WashU) St Louis Missouri
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.
Eligibility Criteria
Inclusion Criteria:
1. Study participant has provided informed consent
2. Age ≥ 18 years
3. CKD Stages 3-5D regardless of kidney transplantation status
4. CKD5D patients receiving maintenance hemodialysis for at least 3 months
5. Clinically indicated treatment for renal hyperparathyroidism, renal osteodystrophy and/or Osteoporosis
6. 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:
1. 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)
2. Currently receiving investigational procedures/drugs from another study while participating in this study
3. 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
4. New use of cinacalcet over the prior 6 months
5. Use of Zoledronic Acid (Reclast) less than 24 months from study enrollment for patients with eGFR \
Source: ClinicalTrials.gov (NCT05880914). StuddyBuddy aggregates publicly available trial information.