Using microRNA to improve treatment for renal osteodystrophy
Precision Medicine Approaches to Renal Osteodystrophy
This study is testing if a new method using microRNA can help doctors better understand bone health in people with chronic kidney disease and improve their treatment for renal osteodystrophy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Washington University School of Medicine Academic / other |
| Drugs / interventions | denosumab, romosozumab |
| Locations | 1 site (St Louis, Missouri) |
| Trial ID | NCT05880914 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with chronic kidney disease stages 3-5D, particularly those undergoing hemodialysis and requiring treatment for renal hyperparathyroidism or renal osteodystrophy.
Not a fit: Patients currently involved in other investigational studies or those who have recently received specific bone-active treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective and personalized treatments for patients suffering from renal osteodystrophy.
How similar studies have performed: Preliminary data suggests that similar approaches using biomarkers for bone turnover have shown promise, but this specific microRNA method is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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 \<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 this trial is running
St Louis, Missouri
- Washington University in St. Louis (WashU) — St Louis, Missouri, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.