Precision Medicine Approaches to Renal Osteodystrophy

Launched by THOMAS NICKOLAS, MD MS · May 26, 2023

Keywords

ClinConnect Summary

This clinical trial, titled "Precision Medicine Approaches to Renal Osteodystrophy," is looking at a new way to understand and treat a bone condition called renal osteodystrophy, which affects patients with chronic kidney disease. The researchers aim to find a non-invasive method using microRNA as a potential biomarker that can help determine the type of bone turnover in these patients. Currently, the standard method of testing involves a bone biopsy, which is not practical for most patients, and existing blood tests don't provide enough clarity for doctors to make confident treatment decisions.

To participate in this study, individuals must be at least 18 years old and have chronic kidney disease in stages 3 to 5D, including those on hemodialysis for at least three months. Participants should also have a medical need for treatment related to renal osteodystrophy or secondary hyperparathyroidism. Those who join the study can expect to go through some tests and procedures to help researchers gather information about their bone health without the need for invasive biopsies. It's important to note that individuals with certain medical conditions or who are currently involved in other clinical studies may not be eligible for this trial.

Gender

ALL

Eligibility 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