Hectorol for Chronic Kidney Disease with Hyperparathyroidism

Recruiting at 61 trial locations

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Sanofi

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

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®.

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.

Treatment Details

Interventions

• Calcitriol (Vitamin D Analog)
• Doxercalciferol (Vitamin D Analog)

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