An Open-Label, Randomized, Parallel Group Study to Assess the Safety and Efficacy of Hectorol® (doxercalciferol capsules) in Pediatric Patients with Chronic Kidney Disease Stages 3 and 4 with Secondary Hyperparathyroidism Not Yet on Dialysis

  • STATUS
    Recruiting
Updated on 11 June 2020

Summary

This is a randomized, open label, parallel, active comparator study in patients aged 5– 18 years with Chronic Kidney Disease (CKD) Stages 3 and 4 and secondary hyperparathyroidism (SHPT) not yet on dialysis.

The study aims to evaluate the effect of Hectorol® capsules in reducing elevated levels of intact parathyroid hormone (iPTH).

 

Details
Condition Kidney Disease (Pediatric)
Clinical Study IdentifierTX228526
Last Modified on11 June 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

• CKD Stage 3 or 4 not on dialysis, defined as GFR between 15 and 59
mL/min/1.73m2 @ Week 2 visit
• iPTH value > 100 pg/mL for CKD Stage 3 or > 160 pg/mL for CKD, Stage 4 @
week 2 visit
• Weight ≥ 15 kg
• Signed informed consent / assent form

Exclusion Criteria

• Patient serum 25-hydroxyvitamin D level < 30 ng/mL @ screening
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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