Using microRNA to improve treatment for renal osteodystrophy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This investigation focuses on renal osteodystrophy, a condition affecting bone quality in patients with chronic kidney disease. The study aims to explore a microRNA-based approach as a non-invasive biomarker to accurately assess bone turnover, which is crucial for guiding treatment decisions. Current methods, such as bone biopsy and traditional biomarkers, have proven inadequate for determining the type of bone turnover in these patients. By utilizing miRNAseq analysis, the study seeks to provide a more reliable means of identifying high or low turnover states in renal osteodystrophy.

Why it matters

Who can join: the full rules

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 \<30mL/minute
6. Anticipated or scheduled kidney transplant during the study period or less than 1 year from receiving a kidney transplant
7. For patients with a solid organ transplant, less than 1 year from receiving the transplant
8. 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
9. Metabolic bone diseases not related to the kidney (e.g., Paget's, Osteogenesis Imperfecta)
10. Endocrinopathy (e.g., untreated hyperthyroidism)
11. Malignancy within the last 5 years (except non-melanoma skin cancers or cervical carcinoma in situ)
12. Patient is pregnant or nursing
13. Weight \>300 pounds (scanner limitation)
14. Allergy to tetracycline or demeclocycline
15. Patients on non-aspirin anticoagulants that cannot be reasonably held for biopsy
16. 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

Where it's running

• Washington University in St. Louis (WashU)
  St Louis, Missouri, United States Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.