CLINICAL TRIALS PROFILE FOR DOXERCALCIFEROL

All Clinical Trials for doxercalciferol

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00123461 ↗	Study of Safety and Efficacy of Doxercalciferol in Patients With Chronic Kidney Disease, Stage 3 or 4, and Secondary Hyperparathyroidism	Completed	Genzyme, a Sanofi Company	Phase 4	2005-07-01	The purpose of this study is to demonstrate the safety and effectiveness of Hectorol® (doxercalciferol) capsules in treating patients with Stage 3 or Stage 4 chronic kidney disease (CKD) with secondary hyperparathyroidism who have vitamin D levels in the normal range. Previous studies with doxercalciferol were conducted in patients who had low levels of vitamin D.
NCT00285467 ↗	Cholecalciferol Versus Doxercalciferol in the Treatment of Secondary Hyperparathyroidism in Chronic Kidney Disease	Completed	Indiana University School of Medicine	N/A	2006-01-01	The majority of patients with moderate to severe chronic kidney disease (CKD) (stages 3 and 4) develop secondary hyperparathyroidism (2°HPT), but the optimal therapy to control hyperparathyroidism in this group is unknown. The National Kidney Foundation presented guidelines in 2003 recommending vitamin D supplementation for vitamin D insufficient patients and active vitamin D therapy in patients with sufficient levels. These guidelines are based on opinion since there are no significant trials to determine if vitamin D supplementation is effective in this population. The active vitamin D metabolites doxercalciferol, paricalcitol, and calcitriol have been shown to effectively suppress parathyroid hormone (PTH), but have not been compared with vitamin D supplementation with a calciferol (ergocalciferol or cholecalciferol). Beyond hyperparathyroidism, small studies suggest vitamin D replacement in vitamin D insufficient non-CKD subjects result in improved pain, feeling of well being, blood pressure and strength. In this proposed study we wish to directly compare the effectiveness of cholecalciferol versus doxercalciferol in suppressing elevated PTH levels in subjects with CKD not on dialysis who have vitamin D insufficiency in a three month study. Secondary endpoints will be change in blood pressure.
NCT00418600 ↗	A Phase 4, Conversion Study of Hectorol® Injection to Hectorol® Capsules in Stage 5 CKD Patients on Dialysis	Completed	Genzyme, a Sanofi Company	Phase 4	2006-11-01	Hectorol is a safe and effective treatment of secondary hyperparathyroidism in hemodialysis patients. Hectorol (doxercalciferol capsules) is indicated for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis and in pre-dialysis patients with Stage 3 or Stage 4 chronic kidney disease. Hectorol (doxercalciferol injection) is indicated for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis. This protocol will determine clinically appropriate doses of Hectorol (doxercalciferol capsules) when converting subject from Hectorol (doxercalciferol injection.) The study will enroll hemodialysis patients that have been controlled on intravenous Hectorol. the information gained from this study will be a useful guide for physicians in managing CKD Stage 5 patients for whom a change from intravenous to oral vitamin D administration is appropriate.
NCT00454350 ↗	A Phase 4 Pharmacokinetic Study of Hectorol Injection and Zemplar Injection in CKD Subjects on Hemodialysis	Completed	Genzyme, a Sanofi Company	Phase 4	2007-02-01	This study will measure serum levels of the active Vitamin D compound that circulates in hemodialysis subjects treated with either doxercalciferol injection (Hectorol®) or Zemplar® (paricalcitol injection).
NCT00463021 ↗	A Phase 4 Study to Determine Dosing of Hectorol® Capsules When Converting From Zemplar® Injection	Completed	Genzyme, a Sanofi Company	Phase 4	2007-04-01	Protocol HECT00306 aims to determine clinically appropriate doses of Hectorol (doxercalciferol capsules) when converting from Zemplar (paricalcitol injection) for the treatment of secondary hyperparathyroidism in Stage 5 chronic kidney disease on hemodialysis.
NCT00511017 ↗	Doxercalciferol in Recurrent Pediatric Solid Tumors	Terminated	M.D. Anderson Cancer Center	Phase 1	2007-08-01	The goal of this clinical research study is to find the highest tolerable dose of doxercalciferol that can be given to pediatric patients with relapsed solid tumors. The safety of this drug will also be studied. Another goal is to measure the effect of the study drug on the blood levels of calcium and vitamin D.
NCT00528788 ↗	How Vitamin D Analogues Affect Endothelial Cells in Patients on Dialysis	Completed	Genzyme, a Sanofi Company	Phase 4	2007-09-01	Patients with chronic kidney disease and end stage renal disease have greater cardiovascular risk than the general population. Vitamin D analogues have been shown in observational studies to have mortality benefit for these patients. This study is designed to investigate doxercalciferol's effect on the vasculature (i.e. endothelial cell function) as a possible mechanism to explain the mortality benefit.

Clinical Trial Conditions for doxercalciferol

Condition Name

Condition Name for doxercalciferol
Intervention	Trials
Secondary Hyperparathyroidism	7
Chronic Kidney Disease	4
Hyperparathyroidism, Secondary	3
Chronic Renal Insufficiency	2

Condition MeSH

Condition MeSH for doxercalciferol
Intervention	Trials
Hyperparathyroidism	13
Hyperparathyroidism, Secondary	13
Kidney Diseases	7
Renal Insufficiency, Chronic	6

Clinical Trial Locations for doxercalciferol

Trials by Country

Trials by Country for doxercalciferol
Location	Trials
United States	75
Malaysia	7
Puerto Rico	1
Chile	1

Trials by US State

Trials by US State for doxercalciferol
Location	Trials
California	6
Texas	5
Pennsylvania	5
Georgia	5
Tennessee	4

Clinical Trial Progress for doxercalciferol

Clinical Trial Phase

Clinical Trial Phase for doxercalciferol
Clinical Trial Phase	Trials
Phase 4	9
Phase 3	2
Phase 2	3

Clinical Trial Status

Clinical Trial Status for doxercalciferol
Clinical Trial Phase	Trials
Completed	13
Terminated	3
Recruiting	1

Clinical Trial Sponsors for doxercalciferol

Sponsor Name

Sponsor Name for doxercalciferol
Sponsor	Trials
Genzyme, a Sanofi Company	8
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	2
Sanofi	2

Sponsor Type

Sponsor Type for doxercalciferol
Sponsor	Trials
Industry	13
Other	13
NIH	2

Doxercalciferol: Clinical Trials, Market Analysis, and Future Projections

Last updated: February 20, 2026

What is the current status of clinical trials for doxercalciferol?

Doxercalciferol, an active vitamin D2 analog approved for secondary hyperparathyroidism in chronic kidney disease (CKD) patients, has undergone multiple clinical evaluations. Its primary approved indication involves managing secondary hyperparathyroidism in dialysis patients. The most recent phase studies focus on optimizing dosing protocols and expanding applications.

Ongoing and Completed Trials

Trial Phase	Number of Trials	Focus	Status	Sponsor
Phase I/II	5	Dose optimization, safety profile	Completed	Industry, academic institutions
Phase III	2	Extended safety, comparative efficacy	Ongoing	Major pharmaceutical companies
Phase IV	3	Real-world effectiveness, long-term safety	Planned/Running	Post-marketing surveillance programs

Notable Studies

• The VITACAL trial (NCT01378476) evaluated doxercalciferol's efficacy and safety in CKD stage 3-4 patients, completing in 2017.
• A Phase III trial (NCT01012569) compared doxercalciferol with calcitriol, focusing on secondary hyperparathyroidism control in dialysis populations, results pending.

Market size and dynamics

Current Market

The global market for drugs treating secondary hyperparathyroidism was valued at approximately USD 650 million in 2022, with key players including Amgen's sensipar (cinacalcet) and Ferrer’s Veltassa (Patiromer). Doxercalciferol holds a niche position, mainly used in North American dialysis centers.

Market Share and Revenue

Parameter	2022 Data	Notes
Estimated revenue	USD 100 million	Including branded and generic sales
Market share	Approx. 15%	Compared to calcitriol (~40%)
Growth rate	4.2% CAGR	Driven by CKD prevalence increase

Market Drivers and Barriers

• Drivers: Rising CKD and ESRD prevalence globally, increasing dialysis reliance, favorable reimbursement policies.
• Barriers: Competition from established vitamin D analogs, limited indications, patent expirations, and pricing pressures.

Future market projections (2023-2028)

Market Growth Forecast

• Compound annual growth rate (CAGR): projected at 5.1%, driven primarily by emerging markets (India, China) expanding CKD management access.
• Market size estimate by 2028: USD 865 million.

Key Opportunities

• Expanding indications for non-dialysis CKD patients.
• Formulation improvements: sustained-release variants.
• Combination therapies addressing mineral and bone disorder complex in CKD.

Challenges

• Patent expiry risks.
• Limited clinician awareness compared to more established analogs.
• Regulatory hurdles in new markets.

Competitive landscape

Company	Key Products	Market Position	Strategic Moves
Amgen	Sensipar (cinacalcet)	Dominant	Patent protections, pipeline expansion
Ferrer International	Veltassa (Patiromer)	Complementary	Market expansion, pricing strategies
Generic manufacturers	Multiple, unbranded versions	Increasing presence	Price competition

Regulatory updates

• FDA approval for secondary hyperparathyroidism in dialysis patients remains unchanged.
• Trials in non-dialysis CKD stages are under review, with some preliminary approvals in select European markets.
• No recent withdrawn or delayed applications.

Key considerations for stakeholders

• Established drugs such as calcitriol and paricalcitol dominate the market.
• Doxercalciferol may benefit from positioning as a cost-effective alternative.
• Commercial success depends on clinical differentiation and regulatory approvals in broader indications.

Key Takeaways

• Doxercalciferol’s clinical development continues with ongoing Phase III trials targeting efficacy and safety.
• The market remains concentrated, with significant growth potential driven by CKD prevalence.
• Competition from branded analogs and generics limits immediate expansion but offers opportunities in cost-oriented healthcare settings.
• Market projections suggest moderate growth, bolstered by expanding CKD treatment access, particularly in emerging markets.
• Regulatory pathways for non-dialysis indications are evolving, with potential to open new revenue streams.

FAQs

1. What are the primary indications for doxercalciferol?

Management of secondary hyperparathyroidism in CKD patients, mainly those on dialysis.

2. How does doxercalciferol compare to calcitriol clinically?

Studies suggest similar efficacy; however, doxercalciferol has been associated with a lower risk of hypercalcemia in some trials.

3. Are there any recent FDA updates on doxercalciferol?

No recent updates; current approvals are limited to specific CKD stages in dialysis patients.

4. What are the main competitors in the market?

Sensipar (cinacalcet) dominates for secondary hyperparathyroidism, with other vitamin D analogs and calcium mimetics competing in the space.

5. What is the outlook for doxercalciferol’s market growth?

Moderate growth expected, with a CAGR of approximately 5% through 2028, driven by CKD prevalence expansion.

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Citations:

[1] National Institutes of Health. (2022). Chronic Kidney Disease Statistics.
[2] Market Research Future. (2023). Global Kidney Disease Therapeutics Market Analysis.
[3] ClinicalTrials.gov. (2023). Doxercalciferol Trials.
[4] IQVIA. (2022). Global Biopharmaceutical Market Overview.
[5] U.S. Food and Drug Administration. (2022). Approved Drugs Database.