Precision Medicine Approaches to Renal Osteodystrophy

AAAU1119

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.

2022-12-21

2026-08-17

2027-06-30

Recruiting

Early phase I

40

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

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Patients with kidney disease and requiting treatment for osteoporosis will be managed as per clinical indications. The bone turnover response, measured by bone biopsy, will be compared to circulating levels of miRNAs and bone turnover markers.', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}

2023-07-17