Summary

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

Description

Summary

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

Details

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

Keywords

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

Eligibility

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.

Locations

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

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Sanofi
Links
Sign up for this study
ID
NCT02859896
Phase
Phase 3
Study Type
Interventional
Last Updated