Hectorol for Chronic Kidney Disease with Hyperparathyroidism

Recruiting at 61 trial locations

Overseen By Trial Transparency email recommended (Toll free number for US & Canada)

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

84 Participants Needed

Trial Summary

What is the purpose of this trial?

Primary Objective: Evaluate the effect of Hectorol® capsules in reducing elevated levels of intact parathyroid hormone (iPTH). Secondary Objectives: * Evaluate the safety profile of Hectorol® capsules versus Rocaltrol® (calcitriol) capsules. * Determine the pharmacokinetic profile of 1,25-dihydroxyvitamin D2 after administration of Hectorol®.

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.

What evidence supports the effectiveness of the drug Hectorol for treating chronic kidney disease with hyperparathyroidism?

Research shows that doxercalciferol, a component of Hectorol, effectively reduces parathyroid hormone levels and improves bone health in patients with chronic kidney disease and hyperparathyroidism. It is as effective as calcitriol, another vitamin D analog, in controlling these conditions. ^{1 2 3 4 5}

Is Hectorol (doxercalciferol) safe for treating hyperparathyroidism in chronic kidney disease?

Doxercalciferol is generally safe for treating hyperparathyroidism in chronic kidney disease, with studies showing it effectively reduces parathyroid hormone levels. It may cause fewer issues with high calcium levels compared to some other treatments, but further studies are needed to confirm its long-term safety and effectiveness. ^{2 3 4 6 7}

How is the drug doxercalciferol unique in treating hyperparathyroidism in chronic kidney disease?

Doxercalciferol is unique because it is a synthetic vitamin D analog that is activated by the liver, not the kidneys, making it suitable for patients with kidney issues. It effectively reduces parathyroid hormone levels with potentially less risk of high calcium levels compared to some other treatments. ^{1 2 3 4 5}

Research Team

Clinical Sciences & Operations

Principal Investigator

Sanofi

Eligibility Criteria

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 am between 5 and 18 years old.

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

Signed informed consent/assent form

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 have a long-term gut condition like severe diarrhea or ulcerative colitis.

Timeline

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

Treatment Details

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.

Participant Groups

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

References

1. Germany pubmed.ncbi.nlm.nih.gov

Effect of doxercalciferol (1alpha-hydroxyvitamin D2) on PTH, bone turnover and bone mineral density in a hemodialysis patient with persistent secondary hyperparathyroidism post parathyroidectomy. [2019]

2. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Clinical uses of 1-alpha-hydroxy-ergocalciferol. [2021]

3. Germany pubmed.ncbi.nlm.nih.gov

Converting hemodialysis patients from intravenous paricalcitol to intravenous doxercalciferol - a dose equivalency and titration study. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Calcitriol and doxercalciferol are equivalent in controlling bone turnover, suppressing parathyroid hormone, and increasing fibroblast growth factor-23 in secondary hyperparathyroidism. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Strategies to minimize bone disease in renal failure. [2016]

6. United States pubmed.ncbi.nlm.nih.gov

Doxercalciferol treatment of secondary hyperparathyroidism. [2014]

7. United States pubmed.ncbi.nlm.nih.gov

Doxercalciferol safely suppresses PTH levels in patients with secondary hyperparathyroidism associated with chronic kidney disease stages 3 and 4. [2019]