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Last Updated: February 11, 2025

CLINICAL TRIALS PROFILE FOR DOXERCALCIFEROL


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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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Doxercalciferol

Condition Name

Condition Name for Doxercalciferol
Intervention Trials
Secondary Hyperparathyroidism 7
Chronic Kidney Disease 4
Hyperparathyroidism, Secondary 3
Renal Osteodystrophy 2
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Condition MeSH

Condition MeSH for Doxercalciferol
Intervention Trials
Hyperparathyroidism, Secondary 13
Hyperparathyroidism 13
Kidney Diseases 7
Renal Insufficiency, Chronic 6
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Clinical Trial Locations for Doxercalciferol

Trials by Country

Trials by Country for Doxercalciferol
Location Trials
United States 75
Malaysia 7
Chile 1
Puerto Rico 1
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Trials by US State

Trials by US State for Doxercalciferol
Location Trials
California 6
Texas 5
Pennsylvania 5
Georgia 5
Tennessee 4
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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
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Clinical Trial Status

Clinical Trial Status for Doxercalciferol
Clinical Trial Phase Trials
Completed 13
Terminated 3
Unknown status 1
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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
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Sponsor Type

Sponsor Type for Doxercalciferol
Sponsor Trials
Other 13
Industry 13
NIH 2
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Doxercalciferol: Clinical Trials Update, Market Analysis, and Projections

Introduction to Doxercalciferol

Doxercalciferol, also known by its brand name Hectorol, is a synthetic vitamin D2 analog used primarily in the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD), particularly those on dialysis. Here, we will delve into the current clinical trials, market analysis, and future projections for this drug.

Current Clinical Trials

Several clinical trials are ongoing or have recently been completed to assess the safety and efficacy of doxercalciferol in various patient populations.

Safety and Efficacy in CKD Patients

  • An open-label, randomized, single-arm, multicenter study is currently recruiting patients to assess the safety and efficacy of doxercalciferol injection in patients with CKD and SHPT on dialysis. This study, sponsored by Sanofi, aims to evaluate the therapeutic benefits of doxercalciferol in this patient group[1][5].

Completed Trials

  • A study completed in 2015 evaluated the safety and efficacy of doxercalciferol in patients with CKD stage 3 or 4 and SHPT. This trial, sponsored by Genzyme (a Sanofi company), provided valuable data on the use of doxercalciferol in managing SHPT in these patients[1].

Terminated Trials

  • A trial focused on the mineral metabolism and vascular effects of vitamin D therapy in kidney transplant patients was terminated due to slow enrollment and the departure of the principal investigator from Emory University[1].

Therapeutic Potential Beyond CKD

Doxercalciferol is being explored for its potential in treating various other conditions beyond SHPT in CKD patients.

Cancer and Neurodegenerative Disorders

  • Research suggests that doxercalciferol could be a viable scaffold for developing SIRT1 inhibitors, which have implications for treating complex diseases such as cancer and neurodegenerative disorders. Molecular dynamics simulations have shown that doxercalciferol maintains stability in SIRT1 complexes, indicating its therapeutic potential[1].

Acute Myeloid Leukemia (AML)

  • Studies have shown that vitamin D-based regimens, including doxercalciferol, can enhance cell death in AML by activating specific signaling pathways. This provides a rationale for future clinical trials targeting AML with doxercalciferol[1].

Market Analysis

The market for doxercalciferol is growing due to several key factors.

Market Size and Forecast

  • The doxercalciferol market was valued at USD 339.6 million in 2023 and is projected to reach USD 555.2 million by 2030, growing at a CAGR of 8.4% from 2024 to 2030[2].

Drivers of Market Growth

  • Rising Prevalence of Vitamin D Deficiency: The increasing incidence of vitamin D deficiency globally is driving the demand for doxercalciferol. This is exacerbated by aging populations and lifestyle changes that contribute to nutrient deficiencies[3].
  • Expanding Indications for Use: Doxercalciferol is gaining traction due to its potential benefits in treating various conditions beyond SHPT, including certain cancers and cardiovascular diseases[3].
  • Growing Trend towards Personalized Medicine: The shift towards personalized medicine is opening up opportunities for therapeutic interventions tailored to individual patient needs, further driving the market[3].

Market Segmentation

  • The doxercalciferol market is segmented by type (injection and capsule) and application (SHPT in patients with CKD on dialysis, SHPT in patients with stage 3 or 4 CKD). New convenient formulations, such as extended-release capsules and injectable preparations, are also contributing to market growth[3].

Future Trends and Projections

Several trends are expected to shape the future of the doxercalciferol market.

Advances in Pharmaceutical Formulations

  • New formulations are being developed to improve patient compliance and therapeutic outcomes. These include extended-release capsules and more convenient injectable preparations[3].

Increased Focus on Kidney Care

  • Global awareness and policies aimed at improving kidney care are increasing the demand for doxercalciferol, particularly among patients with CKD. This is reflected in the growing number of research studies focused on improving outcomes for CKD patients using vitamin D analogs[3].

Personalized Medicine

  • The growing interest in personalized medicine is expected to continue, offering tailored therapeutic interventions for patients with vitamin D deficiency or related conditions. This shift is likely to improve treatment outcomes and further drive market growth[3].

Key Takeaways

  • Clinical Trials: Ongoing trials are evaluating the safety and efficacy of doxercalciferol in CKD patients, while past trials have established its benefits in managing SHPT.
  • Therapeutic Potential: Doxercalciferol shows promise in treating conditions beyond CKD, including cancer and neurodegenerative disorders.
  • Market Growth: The market is driven by rising vitamin D deficiency, expanding indications, and advances in pharmaceutical formulations.
  • Future Trends: Personalized medicine and increased focus on kidney care are expected to continue driving market growth.

FAQs

What is doxercalciferol primarily used for?

Doxercalciferol is primarily used to treat secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD), especially those on dialysis.

What are the current clinical trials focusing on?

Current clinical trials are assessing the safety and efficacy of doxercalciferol injection in patients with CKD and SHPT on dialysis, as well as exploring its potential in other conditions like cancer and neurodegenerative disorders.

What is the projected market size for doxercalciferol by 2030?

The doxercalciferol market is projected to reach USD 555.2 million by 2030, growing at a CAGR of 8.4% from 2024 to 2030[2].

What are the key drivers of the doxercalciferol market growth?

Key drivers include the rising prevalence of vitamin D deficiency, expanding indications for use, and advances in pharmaceutical formulations.

How is the trend towards personalized medicine impacting the doxercalciferol market?

The trend towards personalized medicine is opening up opportunities for tailored therapeutic interventions, improving treatment outcomes and driving market growth.

Sources

  1. LARVOL Sigma: Doxercalciferol News - LARVOL Sigma
  2. Verified Market Research: Doxercalciferol Market Size, Growth, Scope, Share and Forecast
  3. The Insight Partners: Doxercalciferol Market SWOT Analysis by 2031
  4. Straits Research: Global Clinical Trials Market Size, Top Share, Trends, Forecast by ...
  5. Chinese Clinical Trial Register (ChiCTR): An Open-Label, Randomized, Single-arm, Multicenter Study to Assess the Safety and Efficacy of Doxercalciferol Injection in Patients With Chronic Kidney Disease

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