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New blood test could end painful bone biopsies for kidney disease patients

NCT ID NCT05880914

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2022

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Washington University in St. Louis (WashU)

    RECRUITING

    St Louis, Missouri, 63110, United States

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