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Vitamin D Analog

Hectorol for Chronic Kidney Disease with Hyperparathyroidism

Phase 3

Waitlist Available

Research Sponsored by Sanofi

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female aged 5 to 18 years old

Chronic kidney disease (CKD) Stage 3 or 4 not on dialysis, defined as glomerular filtration rate (GFR) between 15 and 59 mL/min/1.73m^2 (established by Schwartz equation) at Week -2 visit

Must not have

The patient currently has a chronic gastrointestinal disease (ie, malabsorption, severe chronic diarrhea, chronic ulcerative colitis, or ileostomy)

The patient currently has primary hyperparathyroidism or has had a total parathyroidectomy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing the effect of Hectorol capsules in reducing elevated levels of iPTH, as well as the safety profile of Hectorol capsules compared to Rocaltrol capsules.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include allergic reactions to the medication components, high calcium levels which can cause stomach pain or confusion, and potential interactions with other drugs affecting mineral balance.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 5 and 18 years old.

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

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I weigh at least 15 kilograms.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have primary hyperparathyroidism or have had all my parathyroid glands removed.

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I currently have cancer.

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I am allergic to certain vitamin D medications.

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I have had heart problems in the last year.

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I might need dialysis within the next 3 months.

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I cannot swallow pills similar in size to Hectorol or Rocaltrol.

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I am currently using aluminum or magnesium-based binders.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: HectorolExperimental Treatment1 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: RocaltrolActive Control1 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.

0 / 11Eligibility criteria met