No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
40 (estimated)
Sponsor
Thomas Nickolas · Other
Who this trial is looking for
This trial is looking for adults aged 18 and older who have chronic kidney disease and related bone conditions. Participants will undergo tests to help find a new way to track their bone health without invasive procedures.
Are You a Good Fit for This Trial?
Must not be takingEtelcalcetideBisphosphonateDenosumabTeriparatideAbaloparatideRomosozumab
Rules you outUnstable medical conditionEndocrinopathyMalignancyMetabolic bone diseases not related to kidneys
You may be able to join if
I am 18 years or older
I have chronic kidney disease stages 3-5D
I have been on hemodialysis for at least 3 months
I need treatment for bone-related issues
My blood tests show specific levels for bone turnover
You may not be able to join if
I have been in another clinical trial within the last 30 days
I am currently unstable medically based on my health history
I have had cancer in the last 5 years
I am pregnant or nursing
I weigh more than 300 pounds
I cannot be treated for a biopsy due to my medications
I have a serious endocrine problem like untreated hyperthyroidism
I have other metabolic bone diseases not related to my kidneys
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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. …
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.
Trial Locations
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Status
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 o…
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
Contacts
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