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Clinical trial No longer in our active list Phase 2 Interventional Ages 18 and up

Testing a new vitamin D treatment for kidney failure patients on dialysis

Official title: DePTH: De-emphasize Parathyroid Hormone

Run by University of Washington · NCT06288451 · Data updated 2026-05-14

This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.

This study is testing a new oral vitamin D treatment for kidney failure patients on dialysis to see if it can improve their bone health and lower heart risks compared to the usual vitamin D injections.

More Kidney Failure, Chronic trials

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment90 (estimated)
SponsorUniversity of Washington
Academic / other
Locations1 site (Seattle, Washington)
Trial IDNCT06288451 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 and older with kidney failure on in-center hemodialysis and elevated parathyroid hormone levels.

Probably not a fit

Patients with severe secondary hyperparathyroidism or those who have had a parathyroidectomy may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The DePTH Study is a 12-month clinical trial that investigates the effects of a low fixed-dose oral calcitriol on patients with secondary hyperparathyroidism and kidney failure undergoing hemodialysis. This pragmatic, randomized, open-label trial compares the new treatment to the standard care of variably-dosed intravenous activated vitamin D. The study aims to assess the safety and effectiveness of the oral treatment in improving mineral metabolism, bone turnover, and reducing cardiovascular risks associated with kidney disease. Participants will be recruited from hemodialysis centers in Seattle and will be randomized to receive either the new treatment or the usual care.

Why it matters

Potential benefit: If successful, this study could provide a safer and more effective treatment option for patients with kidney failure and secondary hyperparathyroidism.

How similar studies have gone: While the approach of using low fixed-dose oral calcitriol is novel, previous studies have indicated that current high-dose vitamin D treatments may not improve health outcomes, suggesting a need for alternative strategies.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Age \>=18 years
2. Kidney failure treated with in-center hemodialysis
3. PTH \>=150 pg/mL x 2 consecutive measures at least 1 month apart or active IV activated vitamin D treatment using the NKC protocol

Exclusion Criteria:

1. History of parathyroidectomy or calciphylaxis
2. Severe secondary hyperparathyroidism (PTH \>=600 pg/mL x 2 consecutive measures at least 1 month apart despite paricalcitol \>=10 mcg 3x/week or doxercalciferol \>=5 mcg 3x/week or cinacalcet \>30 mg/d)
3. Calcium \>9.8 mg/dL
4. Phosphate \>9 mg/dL
5. Cholestyramine, phenytoin/phenobarbital, or ketoconazole use
6. Breast-feeding mothers
7. Inability to provide informed consent and no legally authorized representative

Where it's running

  • University of Washington
    Seattle, Washington, United States     Recruiting

Study contacts

  • Principal investigator: Simon Hsu, MD, MS — University of Washington
  • Study coordinator: Simon Hsu, MD, MS
  • Email: sihsu@uw.edu
  • Phone: (206) 616-5916

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Kidney Failure, Chronic 13Chronic Kidney Disease Mineral and Bone Disorder 5University of Washington 1989
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.