RECRUITING

Precision Medicine Approaches to Renal Osteodystrophy

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Conditions

Renal OsteodystrophyChronic Kidney DiseasesCKD-MBDBone Turnover Rate DisorderSecondary HyperparathyroidismBone biopsymicroRNAHR-pQCTBone biomarkersBone imaging

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Precision Medicine Approaches to Renal Osteodystrophy

Quick Facts

Study Start:2022-12-21
Study Completion:2027-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05880914

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Study participant has provided informed consent
  2. 2. Age ≥ 18 years
  3. 3. CKD Stages 3-5D regardless of kidney transplantation status
  4. 4. CKD5D patients receiving maintenance hemodialysis for at least 3 months
  5. 5. Clinically indicated treatment for renal hyperparathyroidism, renal osteodystrophy and/or Osteoporosis
  6. 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
  1. 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. 2. Currently receiving investigational procedures/drugs from another study while participating in this study
  3. 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. 4. New use of cinacalcet over the prior 6 months
  5. 5. Use of Zoledronic Acid (Reclast) less than 24 months from study enrollment for patients with eGFR \<30mL/minute
  6. 6. Anticipated or scheduled kidney transplant during the study period or less than 1 year from receiving a kidney transplant
  7. 7. For patients with a solid organ transplant, less than 1 year from receiving the transplant
  8. 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. 9. Metabolic bone diseases not related to the kidney (e.g., Paget's, Osteogenesis Imperfecta)
  10. 10. Endocrinopathy (e.g., untreated hyperthyroidism)
  11. 11. Malignancy within the last 5 years (except non-melanoma skin cancers or cervical carcinoma in situ)
  12. 12. Patient is pregnant or nursing
  13. 13. Weight \>300 pounds (scanner limitation)
  14. 14. Allergy to tetracycline or demeclocycline
  15. 15. Patients on non-aspirin anticoagulants that cannot be reasonably held for biopsy
  16. 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

Contacts and Locations

Study Contact

Maria Aponte, MD
CONTACT
212-342-4678
maa2308@cumc.columbia.edu
Thomas L Nickolas, MD, MS
CONTACT
212-305-9847
tln2001@cumc.columbia.edu

Principal Investigator

Thomas Nickolas, MD, MS
PRINCIPAL_INVESTIGATOR
Professor of Medicine at the Columbia University Medical Center, Dept of Medicine Nephrology

Study Locations (Sites)

Columbia University Irving Medical Center
New York, New York, 10032
United States

Collaborators and Investigators

Sponsor: Thomas Nickolas, MD MS

  • Thomas Nickolas, MD, MS, PRINCIPAL_INVESTIGATOR, Professor of Medicine at the Columbia University Medical Center, Dept of Medicine Nephrology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-21
Study Completion Date2027-06-30

Study Record Updates

Study Start Date2022-12-21
Study Completion Date2027-06-30

Terms related to this study

Keywords Provided by Researchers

  • Bone biopsy
  • microRNA
  • HR-pQCT
  • Bone biomarkers
  • Bone imaging

Additional Relevant MeSH Terms

  • Renal Osteodystrophy
  • Chronic Kidney Diseases
  • CKD-MBD
  • Bone Turnover Rate Disorder
  • Secondary Hyperparathyroidism