Hectorol for Chronic Kidney Disease with Hyperparathyroidism

No longer recruiting at 84 trial locations

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Age: < 65

Sex: Any

Trial Phase: Phase 3

Sponsor: Sanofi

Must not be taking: Cinacalcet, Vitamin D sterols

Disqualifiers: Heart disease, Gastrointestinal disease, Malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 28 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests Hectorol capsules to determine if they can lower high parathyroid hormone levels in people with chronic kidney disease. It also compares the safety of Hectorol to Rocaltrol (Calcitriol). Participants will help researchers understand how the body processes Hectorol. Children and teens aged 5 to 18 with chronic kidney disease, not on dialysis, and with high parathyroid hormone levels, might be suitable candidates. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Do I need to stop my current medications to join the trial?

The trial requires that you stop using certain medications like cinacalcet or vitamin D therapies such as calcitriol, doxercalciferol, or paricalcitol at least 14 days before starting. If you use aluminum or magnesium-based binders, you cannot participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that doxercalciferol, also known as Hectorol, is generally safe for people with chronic kidney disease. One study found that patients with an overactive parathyroid gland who took doxercalciferol experienced lower hormone levels without major problems, indicating the treatment can safely reduce hormone levels.

Another study examined patients on dialysis, a treatment for kidney failure, who had previously taken oral Hectorol. The study found the treatment to be safe, though some patients experienced allergic reactions. Doctors should monitor calcium and phosphorus levels during treatment to prevent issues.

Overall, studies suggest that doxercalciferol is generally safe but may have some risks that require monitoring. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatment for chronic kidney disease with hyperparathyroidism, which often includes daily doses of Calcitriol (Rocaltrol), Hectorol (Doxercalciferol) offers a unique dosing schedule. It is administered only two to three times a week, potentially improving patient compliance and quality of life. Researchers are excited because Hectorol uses an active ingredient that allows for a tailored dose, aiming to optimize the management of parathyroid hormone levels more effectively. This targeted approach could lead to better outcomes with fewer side effects compared to existing therapies.

What evidence suggests that Hectorol might be an effective treatment for chronic kidney disease with hyperparathyroidism?

Research has shown that doxercalciferol, the main ingredient in Hectorol, helps lower high levels of intact parathyroid hormone (iPTH) in people with chronic kidney disease. One study found that patients taking doxercalciferol experienced a 46% drop in iPTH levels after 24 weeks, while those on a placebo saw no change. Another study reported an average 27% reduction in iPTH levels for patients using doxercalciferol. These findings suggest that doxercalciferol can effectively manage high iPTH levels in people with chronic kidney disease. Participants in this trial will receive either Hectorol (Doxercalciferol) or Rocaltrol (Calcitriol) to evaluate their effectiveness in managing iPTH levels. ^{1 3 6 7 8}

Who Is on the Research Team?

Clinical Sciences & Operations

Principal Investigator

Sanofi

Are You a Good Fit for This Trial?

This trial is for kids aged 5-18 with moderate to severe chronic kidney disease not on dialysis, with specific levels of parathyroid hormone indicating secondary hyperparathyroidism. They must be able to swallow capsules and have no allergies to vitamin D analogs, no recent heart issues, or use of certain medications.

Inclusion Criteria

I have moderate to severe kidney disease but am not on dialysis.

Signed informed consent/assent form

I weigh at least 15 kilograms.

Exclusion Criteria

I have taken cinacalcet or vitamin D drugs like calcitriol in the last 14 days.

Your corrected calcium level is higher than 10 mg/dL at the Week -2 visit.

I currently have cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Hectorol or Rocaltrol with dose titration based on iPTH management

28 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Calcitriol
• Doxercalciferol

Trial Overview The trial tests Hectorol® (Doxercalciferol) against Rocaltrol® (Calcitriol) in reducing high parathyroid hormone levels in children. It also looks at Hectorol's safety profile and how the body processes it.

How Is the Trial Designed?

Group I: Hectorol Experimental Treatment 1 Intervention

Hectorol (Doxercalciferol) will be administered orally two to three times weekly dependent on patient age. A dose titration scheme is used to individualize the dose to the patient's iPTH management.

Group II: Rocaltrol Active Control 1 Intervention

Rocaltrol (Calcitriol) will be administered orally seven days/week. A dose titration scheme is used to individualize the dose to the patient's iPTH management.

Who Is Running the Clinical Trial?

Sanofi

Lead Sponsor

Trials

2,246

Recruited

4,085,000+

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico

Sanofi

Chief Medical Officer

MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2827596/

A Randomized Trial of Cholecalciferol versus ... The PTH decreased by 27% ± 34% in the doxercalciferol group (P = 0.002) and decreased by 10% ± 31% in the cholecalciferol group (P = 0.16), but the difference ...

2. kidneyfund.org kidneyfund.org/assets/pdf/financial-assistance/hectorol-pi.pdf

HECTOROL® doxercalciferol Hectorol Injection has been evaluated for safety in 70 patients with chronic renal disease on hemodialysis (who had been previously treated with oral ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0272638604001416

Doxercalciferol safely suppresses PTH levels in patients ... Results: Mean plasma iPTH level decreased by 46% from baseline after 24 weeks of doxercalciferol treatment (P <0.001), but was unchanged with placebo. After 6 ...

4. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2008/021027s015lbl.pdf

HECTOROL - doxercalciferol injection, solution Hectorol is indicated for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis. CONTRAINDICATIONS. Hectorol ...

5. frontiersin.org frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2025.1574679/pdf

Efficacy and safety of intermittent The results of this open-label, prospective, multicenter study provide valuable insights into the efficacy and safety of intermittent.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12021602/

Efficacy and safety of intermittent intravenous doxercalciferol ... This phase II, open-label, prospective, multicenter study evaluated the efficacy and safety of intermittent intravenous doxercalciferol in treating secondary ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT00285467?term=DOXERCALCIFEROL&viewType=Table&rank=10

Study Details | Cholecalciferol Versus Doxercalciferol in the ... The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such ...

8. hectorol.com hectorol.com/aboutthedisease

SHPT Patients with CKD Your doctor should monitor your calcium, phosphorus and PTH levels. Serious allergic reactions (including fatal outcome) have been reported in patients on ...