Testing a new vitamin D treatment for kidney failure patients on dialysis
DePTH: De-emphasize Parathyroid Hormone
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.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Washington Academic / other |
| Locations | 1 site (Seattle, Washington) |
| Trial ID | NCT06288451 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with kidney failure on in-center hemodialysis and elevated parathyroid hormone levels.
Not a fit: Patients with severe secondary hyperparathyroidism or those who have had a parathyroidectomy may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Seattle, Washington
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.