Actively Recruiting
Precision Medicine Approaches to Renal Osteodystrophy
Led by Thomas Nickolas · Updated on 2025-06-27
40
Participants Needed
1
Research Sites
236 weeks
Total Duration
On this page
Sponsors
T
Thomas Nickolas
Lead Sponsor
I
Indiana University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Precision Medicine Approaches to Renal Osteodystrophy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant has provided informed consent
- Age 18 years or older
- Diagnosed with chronic kidney disease (CKD) stages 3 to 5D, regardless of kidney transplant status
- CKD stage 5D patients must have been on maintenance hemodialysis for at least 3 months
- Receiving clinically indicated treatment for renal hyperparathyroidism, renal osteodystrophy, or osteoporosis
- Parathyroid hormone (PTH), bone specific alkaline phosphatase (BSAP), and CTX meet defined thresholds for low or high turnover renal osteodystrophy, or bone biopsy evidence of low or high turnover
You will not qualify if you...
- Currently participating in or within 30 days of ending treatment in another investigational drug or device study
- Receiving investigational procedures or drugs from another study during this study
- Use of etelcalcetide, bisphosphonate, denosumab, teriparatide, abaloparatide, or romosozumab within 6 months before enrollment, except if changing bone-active agent class to alter bone turnover
- New use of cinacalcet within 6 months prior to enrollment
- Use of Zoledronic Acid (Reclast) less than 24 months before enrollment for patients with eGFR below 30 mL/min
- Anticipated or scheduled kidney transplant during the study or less than 1 year since transplant
- Solid organ transplant received less than 1 year prior
- Unstable medical condition as judged by investigator
- Metabolic bone diseases not related to kidney (e.g., Paget's disease, Osteogenesis Imperfecta)
- Endocrinopathy (e.g., untreated hyperthyroidism)
- Malignancy within last 5 years except non-melanoma skin cancers or cervical carcinoma in situ
- Pregnancy or nursing
- Weight over 300 pounds (scanner limitation)
- Allergy to tetracycline or demeclocycline
- Use of non-aspirin anticoagulants that cannot be paused for biopsy
- Unable to complete all required study visits or procedures or comply with study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Washington University in St. Louis (WashU)
St Louis, Missouri, United States, 63110
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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