Precision Medicine Approaches to Renal Osteodystrophy

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Thomas Nickolas
Study ID
NCT05880914
Status
Recruiting
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Conditions

  • Bone Turnover Rate Disorder
  • CKD-MBD
  • Chronic Kidney Diseases
  • Renal Osteodystrophy
  • Secondary Hyperparathyroidism

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • miRNAseq analysis — PROCEDURE
    Identify miRNA in serum and prepare a miRNA sequencing library for novel analysis.
  • Standard treatment for bone disorder — DRUG
    Participants will be prescribed a clinically indicated bone-targeted treatment for osteoporosis or bone disorder related to CKD. (non-experimental)

Study Details

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.

Key Dates

Start date
Dec 21, 2022
Status verified
Jun 2025
Primary completion
Aug 17, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
40 participants (estimated)

Arms

  • Arm: Bone-targeted management - prospective cohort
    Participants diagnosed with a bone disorder related to chronic kidney disease (CKD) and undergoing a clinically indicated treatment for bone disease. Participants will have some questionnaires, research blood draws, bone scans and a bone biopsy. There will be a total of 4 visits over six months for data collection.

Primary Outcome Measure

Correlation between miRNA panel to discriminate changes in bone turnover. [ Time Frame: Five years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University in St. Louis (WashU)St LouisMissouri63110
Thomas L Nickolas, MD MS
[email protected]
212-305-9847
Maria Alejandra Aponte, MD
[email protected]
314-273-8827
Thomas L Nickolas, MD, MS (PRINCIPAL_INVESTIGATOR)

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Washington University in St. Louis (WashU)· St Louis, MO

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