New blood test could end painful bone biopsies for kidney disease patients
NCT ID NCT05880914
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is testing whether a blood test that looks at tiny genetic molecules called microRNAs can accurately detect bone problems in people with chronic kidney disease. Currently, doctors rely on a bone biopsy, which is invasive and not practical for most patients. The researchers will compare the blood test results to actual bone tissue samples from 40 participants to see if the test works. If it does, it could make diagnosing and treating bone disease much easier.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could lead to a simple blood test that helps doctors choose the right bone treatment for kidney disease patients without needing a painful bone biopsy.
- What could go wrong
- This is a small, early-stage study with only 40 participants, so the results may not apply to everyone. The test might not be accurate enough to replace current methods.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2022
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
This study will enroll forty adults with moderate to end stage kidney disease, including kidney transplant recipients, who have bone disease in need of treatment.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Washington University in St. Louis (WashU)
RECRUITINGSt Louis, Missouri, 63110, United States
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