NCT05880914Recruiting
Precision Medicine Approaches to Renal Osteodystrophy
Source: ClinicalTrials.gov · Last updated 12 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 40 (estimated)
- First submitted
- 19 May 2023
- Start date
- 21 Dec 2022
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Thomas Nickolas
- Diseases
- Chronic kidney disease
- NCT number
- NCT05880914
What you commit to
- Study type: Observational
- Planned participants: 40
- From 21 Dec 2022 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Anticipated or scheduled kidney transplant during the study period or less than 1 year from receiving a kidney transplant
- For patients with a solid organ transplant, less than 1 year from receiving the transplant
Other illness
- Metabolic bone diseases not related to the kidney (e.g., Paget's, Osteogenesis Imperfecta)
- Malignancy within the last 5 years (except non-melanoma skin cancers or cervical carcinoma in situ)
- Allergy to tetracycline or demeclocycline
Lab values
- Use of Zoledronic Acid (Reclast) less than 24 months from study enrollment for patients with eGFR \<30mL/minute
- 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
Other
- Endocrinopathy (e.g., untreated hyperthyroidism)
- Patient is pregnant or nursing
- Weight \>300 pounds (scanner limitation)
- Patients on non-aspirin anticoagulants that cannot be reasonably held for biopsy
- Patient unable to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the patient and Investigator's knowledge
Who the study is looking for
- 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
- Clinically indicated treatment for renal hyperparathyroidism, renal osteodystrophy and/or Osteoporosis
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Washington University in St. Louis (WashU) Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.