for people ages 5-18 (full criteria)
at Sacramento, California and other locations
study started
estimated completion



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®.

Official Title

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


The total study duration per patient will be approximately up to 28 weeks.


Secondary Hyperparathyroidism-Chronic Kidney Disease Neoplasm Metastasis Kidney Diseases Renal Insufficiency, Chronic Hyperparathyroidism Hyperparathyroidism, Secondary Calcitriol 1 alpha-hydroxyergocalciferol Doxercalciferol (GZ427397) Hectorol Rocaltrol


You can join if…

Open to people ages 5-18


  • Male or female aged 5 to 18 years old.
  • Weight ≥15 kg.
  • Chronic kidney disease (CKD) Stage 3 or 4 not on dialysis, defined as glomerular filtration rate (GFR) between 15 and 59 mL/min/1.73m2 (established by Schwartz equation) at Week -2 visit.

  • Intact parathyroid hormone (iPTH) value >100 pg/mL for CKD Stage 3 or >160 pg/mL for CKD Stage 4, at Week -2 visit.
  • Signed informed consent/assent form.

You CAN'T join if...

  • The patient has a serum 25-hydroxyvitamin D level <30 ng/mL at screening.
  • The patient has a corrected calcium ≥10 mg/dL at the Week -2 visit.
  • The patient has a serum phosphorus >4.5 mg/dL for children 13 to 18 years of age; >5.8 mg/dL for children 5 to 12 years of age at the Week -2 visit.
  • The patient is anticipated to require maintenance hemodialysis within 3 months.
  • The patient used cinacalcet or vitamin D sterol therapies such as calcitriol, doxercalciferol, or paricalcitol within 14 days prior to the baseline visit.
  • The patient has a history of, or active, symptomatic heart disease within 12 months prior to the baseline (Week 0) visit.
  • 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.
  • The patient has an active malignancy.
  • The patient is unable to swallow a capsule in size similar to the Hectorol® and Rocaltrol® capsules.
  • The patient has a history of sensitivity or allergy to doxercalciferol, calcitriol or other vitamin D analogs.
  • The patient currently uses aluminum or magnesium-based binders.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.


  • Investigational Site Number 8400005 accepting new patients
    Sacramento California 95817 United States
  • Investigational Site Number 8400030 accepting new patients
    Madera California 93638 United States


accepting new patients
Start Date
Completion Date
Sign up for this study
Phase 3
Study Type
Last Updated