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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor

1,741 Previous Clinical Trials

1,847,676 Total Patients Enrolled

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,359 Previous Clinical Trials

4,314,502 Total Patients Enrolled

Simon Hsu, MD, MSPrincipal InvestigatorUniversity of Washington

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this clinical trial currently open for enrollment?

"According to clinicaltrials.gov, this ongoing study is actively seeking participants. It was initially listed on 2/21/2024 and last modified on 2/23/2024."

Answered by AI

What is the current number of participants receiving treatment in this particular study?

"Yes, information on clinicaltrials.gov confirms that recruitment is ongoing for this trial. The study was initially listed on 2/21/2024 and last revised on 2/23/2024. Enrollment aims to reach 90 participants at a single site."

Answered by AI

What are the potential risks associated with administering low doses of oral calcitriol to individuals?

"Our evaluation at Power assigns a safety rating of 2 to low-dose oral calcitriol. This score reflects the ongoing Phase 2 trial, indicating some existing safety data without evidence supporting efficacy yet."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

DePTH: De-emphasize PTH

Simon Hsu, MD, MS 2024. "DePTH: De-emphasize PTH". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06288451.

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