Comparative Effects of Doxercalciferol and Calcitriol on Secondary Hyperparathyroidism in ESRD (NCT07640347) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Comparative Effects of Doxercalciferol and Calcitriol on Secondary Hyperparathyroidism in ESRD
98 participantsStarted 2026-07-05
Plain-language summary
Secondary hyperparathyroidism (SHPT) is a common complication of advanced chronic kidney disease (CKD), caused by phosphate retention and vitamin D deficiency, leading to elevated parathyroid hormone (PTH) levels and increased bone and cardiovascular complications. Active vitamin D analogs such as calcitriol and doxercalciferol are used to suppress PTH levels, though they differ in pharmacologic properties and effects on mineral metabolism. Intravenous preparations may offer improved bioavailability and adherence in hemodialysis patients.This randomized controlled trial will be conducted in the Department of Nephrology at Chittagong Medical College Hospital among 98 adult hemodialysis patients with SHPT. Participants will be randomly assigned to receive either intravenous doxercalciferol or oral calcitriol. The study aims to compare their effectiveness in lowering PTH levels and evaluate safety outcomes.
Continuous variables will be expressed as mean ± standard deviation, while categorical variables will be presented as frequencies and percentages. Independent t-tests, chi-square tests, or Fisher's exact tests will be used for statistical comparisons. Data analysis will be performed using SPSS version 27.0, with a p-value \<0.05 considered statistically significant.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Adult patients aged 18 years or older.
. Diagnosed with secondary hyperparathyroidism (SHPT) with elevated serum PTH levels (\>300 pg/mL).
. Undergoing maintenance hemodialysis for at least 3 months.
. Patients on calcitriol therapy within wash out period 40 hrs.
Exclusion criteria
. Patients with known case of primary hyperparathyroidism or parathyroidectomy.
. Serum calcium\>10mg/dL or phosphate\>5.5mg/dL at baseline.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.