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Comparative Effects of Doxercalciferol and Calcitriol on Secondary Hyperparathyroidism in ESRD

NCT07640347 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2026-06-10

No results posted yet for this study

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.

Conditions

  • Lowering Parathyroid Hormone Level in Patients on Hemodioalysis

Interventions

DRUG

Doxercalciferol administration

receive iv doxercalciferol 4 microgram after dialysis for 12 weeks in addition to their standard routine medications.

DRUG

oral calcitriol 0.25 microgram

Control group will receive oral calcitriol 0.25 microgram once daily in addition to their standard routine medications for 12 weeks

Sponsors & Collaborators

  • Chittagong Medical College

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-05
Primary Completion
2027-05-30
Completion
2027-05-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07640347 on ClinicalTrials.gov