Comparative Effects of Doxercalciferol and Calcitriol on Secondary Hyperparathyroidism in ESRD
Starting soon · Not applicable
Conditions studied: Lowering Parathyroid Hormone Level in Patients on Hemodioalysis
In brief
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.
Key facts
- Study ID
- NCT07640347
- Run by
- Chittagong Medical College
- People needed
- 98
- Starts
- 2026-07-05
- Expected to finish
- 2027-05-30
- Last updated by the study team
- 2026-06-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Patients with known case of primary hyperparathyroidism or parathyroidectomy.
- Serum calcium>10mg/dL or phosphate>5.5mg/dL at baseline.
- Active liver disease or significant hepatic dysfunction, Alcoholism.
- History of hypersensitivity to vitamin D analogs.
- Pregnant or breastfeeding women.
- Concurrent use of medications (e.g. bisphosphonates).
- Patients with active malignancy.(e.g.Multiple myeloma,Bronchogenic carcinoma)
Full record on ClinicalTrials.gov
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