Comparative Effects of Doxercalciferol and Calcitriol on Secondary Hyperparathyroidism in ESRD

ConditionLowering Parathyroid Hormone Level in Patients on Hemodioalysis

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorChittagong Medical College

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

Doxercalciferol administration
Drug
receive iv doxercalciferol 4 microgram after dialysis for 12 weeks in addition to their standard routine medications.
oral calcitriol 0.25 microgram
Drug
Control group will receive oral calcitriol 0.25 microgram once daily in addition to their standard routine medications for 12 weeks

Treatment groups

98 Participants

are divided into 2 treatment groups

Group A: Intravenous Doxercalciferol for PTH Reduction in Hemodialysis PatientsExperimental treatment 1 intervention

Group B: oral Calcitriol for PTH Reduction in Hemodialysis PatientsActive comparator 1 intervention

Trial outcomes

Primary outcomes

Change in serum Parathyroid Hormone (PTH) levels

Patients undergoing hemodialysis with secondary hyperparathyroidism will receive intravenous doxercalciferol according to a standardized dosing protocol. The dose will be adjusted based on serum parathyroid hormone (PTH), calcium, and phosphate levels measured periodically. The aim is to evaluate the effectiveness of doxercalciferol in reducing PTH levels

Time frame

12 weeks

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chittagong Medical College

Lead sponsor

Source ClinicalTrials.gov

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