Comparative Effects of Doxercalciferol and Calcitriol on Secondary Hyperparathyroidism in ESRD

June 8, 2026 updated by: A.K.M.Arshadul Abbas, Chittagong Medical College

Effects of Doxercalciferol Compared to Calcitriol for Lowering PTH Level in Hemoodialysis Patients

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Secondary hyperparathyroidism (SHPT), characterized by markedly elevated parathyroid hormone (PTH) levels, arises from the metabolic abnormalities associated with end-stage renal disease (ESRD). It affects the majority of patients undergoing dialysis and contributes to a wide range of complications, including cognitive impairment, bone disease, and cardiovascular morbidity. SHPT develops early during chronic kidney disease (CKD), often beginning in stage G2, when impaired phosphate excretion stimulates increased secretion of PTH. As kidney function declines further, hyperphosphatemia and hypocalcemia become more pronounced, leading to progressive parathyroid gland hyperplasia and excessive hormone production.

Clinically, SHPT is a major component of chronic kidney disease-mineral and bone disorder (CKD-MBD), which is characterized by bone pain, skeletal deformities, spontaneous fractures, soft tissue calcification, and muscle weakness. Persistent elevations in PTH also contribute to vascular calcification, left ventricular hypertrophy, and other cardiovascular complications that significantly increase morbidity and mortality among dialysis patients. Consequently, uncontrolled SHPT adversely affects both quality of life and long-term survival.

Parathyroid hormone plays a central role in calcium and phosphate homeostasis. It maintains serum calcium levels by stimulating bone resorption and enhancing calcium mobilization from the skeleton. Although PTH increases phosphate release from bone, it also promotes phosphate excretion through the kidneys by reducing tubular phosphate reabsorption. In patients with CKD, these regulatory mechanisms become impaired, resulting in chronic elevations of PTH and progressive disturbances in mineral metabolism. Sustained hyperparathyroidism can lead to high-turnover bone disease, renal osteodystrophy, vascular calcification, and increased cardiovascular risk.

Intravenous doxercalciferol and oral calcitriol are commonly used vitamin D receptor activators for the management of SHPT in hemodialysis patients. Calcitriol, the active form of vitamin D, directly binds to vitamin D receptors and effectively suppresses PTH secretion. However, its use is frequently associated with increases in serum calcium and phosphate levels, potentially increasing the risk of vascular calcification. Doxercalciferol, a synthetic vitamin D analog, requires hepatic activation and has been shown to provide effective PTH suppression while producing fewer calcemic effects. These pharmacological differences may influence treatment outcomes and safety profiles in dialysis populations.

Recent evidence suggests that both agents are effective in reducing PTH levels, although intravenous doxercalciferol may offer improved biochemical control and a lower incidence of hypercalcemia. As secondary hyperparathyroidism remains highly prevalent among hemodialysis patients, identifying the most effective and safest therapeutic option is of considerable clinical importance.

In Bangladesh and other low- and middle-income countries, the growing burden of CKD and dependence on maintenance hemodialysis present substantial healthcare challenges. Medication cost, availability, and patient adherence play important roles in treatment selection. Oral calcitriol is widely available and relatively inexpensive, whereas intravenous doxercalciferol may be less accessible in resource-constrained settings. Furthermore, adherence to oral therapy may be affected by pill burden and other practical barriers. Therefore, evidence comparing the efficacy and safety of these treatment options is essential for guiding cost-effective and evidence-based clinical practice.

Despite the widespread use of both agents, high-quality comparative studies in hemodialysis patients from resource-limited settings remain limited. Most available evidence originates from high-income countries, and its applicability to South Asian populations is uncertain. A direct comparison of intravenous doxercalciferol and oral calcitriol with respect to PTH control, biochemical outcomes, safety, and treatment practicality is therefore warranted. This study aims to address this knowledge gap and provide evidence to support optimal management of secondary hyperparathyroidism among hemodialysis patients in resource-constrained environments.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
98

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Adult patients aged 18 years or older.
  2. Diagnosed with secondary hyperparathyroidism (SHPT) with elevated serum PTH levels (>300 pg/mL).
  3. Undergoing maintenance hemodialysis for at least 3 months.
  4. Patients on calcitriol therapy within wash out period 40 hrs.

Exclusion Criteria:

  1. Patients with known case of primary hyperparathyroidism or parathyroidectomy.
  2. Serum calcium>10mg/dL or phosphate>5.5mg/dL at baseline.
  3. Active liver disease or significant hepatic dysfunction, Alcoholism.
  4. History of hypersensitivity to vitamin D analogs.
  5. Pregnant or breastfeeding women.
  6. Concurrent use of medications (e.g. bisphosphonates).
  7. Patients with active malignancy.(e.g.Multiple myeloma,Bronchogenic carcinoma)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intravenous Doxercalciferol for PTH Reduction in Hemodialysis Patients
Experimental subjects will receive an intravenous loading dose of doxercalciferol 4 micrograms after dialysis, in addition to their standard routine medications. Each Dose of doxercalciferol will be given after skin sensitivity test
Drug: Doxercalciferol administration
receive iv doxercalciferol 4 microgram after dialysis for 12 weeks in addition to their standard routine medications.
Active Comparator: oral Calcitriol for PTH Reduction in Hemodialysis Patients
Control group will receive oral calcitriol 0.25 microgram once daily in addition to their standard routine medications for 12 weeks
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in serum Parathyroid Hormone (PTH) levels
Time Frame: 12 weeks
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
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chittagong Medical College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 5, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 5, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 10, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 59.127.1557.013.19.2025.1237

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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