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Vitamin D Analog

Low dose oral calcitriol for Chronic Kidney Disease

Phase 2
Recruiting
Led By Simon Hsu, MD, MS
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

"This trial compares the effects of two different treatments on patients with kidney failure and high levels of parathyroid hormone. One group will receive a fixed dose of oral calcitriol, while the other

Who is the study for?
This trial is for patients with kidney failure on hemodialysis who have a condition called secondary hyperparathyroidism. Participants should not have other health issues that could interfere with the study.Check my eligibility
What is being tested?
The DePTH Study compares two treatments: low fixed-dose oral calcitriol and variably-dosed IV activated vitamin D, to see which better affects mineral metabolism, bone turnover, and serum calcification in patients over 12 months.See study design
What are the potential side effects?
Potential side effects may include high calcium levels, digestive discomfort, or allergic reactions related to the oral or IV medications used in this trial.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in fibroblast growth factor-23
Secondary outcome measures
Change in T50 test of serum calcification propensity
Change in serum bone-specific alkaline phosphatase
Change in serum calcium
+2 more
Other outcome measures
Patient acceptability

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Low dose oral calcitriolExperimental Treatment1 Intervention
Group II: Usual careActive Control1 Intervention

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor
1,750 Previous Clinical Trials
1,840,061 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,377 Previous Clinical Trials
4,315,721 Total Patients Enrolled
Simon Hsu, MD, MSPrincipal InvestigatorUniversity of Washington
~60 spots leftby Feb 2027
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