Safety and Efficacy of Hectorol in Pediatric Patients With Chronic Kidney Disease Stage 3 and 4 With Secondary Hyperparathyroidism Not Yet on Dialysis
Megadott ok: The study was conducted to fulfill a post-marketing commitment (PMC).FDA acknowledged the fulfillment of this PMC.
Key facts
- Where
- Birmingham, Chicago, Durham, Greenville, Hackensack, Houston, Los Angeles, Marshfield, Miami, Minneapolis, Morristown, Nashville, New Haven, New Hyde Park, New York, Pittsburgh, Richmond, Sacramento és Salt Lake City, Egyesült ÁllamokSee the 21 sites
- Phase
- 3. fázis
Where in Egyesült Államok
- Children's of Alabama- Site Number : 8400022Birmingham, Egyesült ÁllamokNo longer taking part
- Rush University Medical Center- Site Number : 8400020Chicago, Egyesült ÁllamokNo longer taking part
- Duke University Medical Center- Site Number : 8400034Durham, Egyesült ÁllamokNo longer taking part
- East Carolina University- Site Number : 8400025Greenville, Egyesült ÁllamokNo longer taking part
- Greenville Memorial Hospital- Site Number : 8400027Greenville, Egyesült ÁllamokNo longer taking part
- Hackensack Meridian Health - Hackensack University Medical Center- Site Number : 8400010Hackensack, Egyesült ÁllamokNo longer taking part
- Texas Children's Hospital- Site Number : 8400013Houston, Egyesült ÁllamokNo longer taking part
- Cedars-Sinai Medical Center- Site Number : 8400033Los Angeles, Egyesült ÁllamokNo longer taking part
- Marshfield Medical Center - Marshfield- Site Number : 8400001Marshfield, Egyesült ÁllamokNo longer taking part
- Nicklaus Children's Hospital - Miami - Southwest 62nd Avenue- Site Number : 8400008Miami, Egyesült ÁllamokNo longer taking part
- University of Miami Hospital- Site Number : 8400006Miami, Egyesült ÁllamokNo longer taking part
- M Health Fairview University of Minnesota Medical Center - West Bank- Site Number : 8400014Minneapolis, Egyesült ÁllamokNo longer taking part
- Goryeb Chidlren's Hospital- Site Number : 8400016Morristown, Egyesült ÁllamokNo longer taking part
- Vanderbilt University Medical Center- Site Number : 8400024Nashville, Egyesült ÁllamokNo longer taking part
- Yale University School of Medicine- Site Number : 8400029New Haven, Egyesült ÁllamokNo longer taking part
- Cohen Children's Medical Center- Site Number : 8400017New Hyde Park, Egyesült ÁllamokNo longer taking part
- The Mount Sinai Hospital- Site Number : 8400007New York, Egyesült ÁllamokNo longer taking part
- UPMC Children's Hospital of Pittsburgh- Site Number : 8400028Pittsburgh, Egyesült ÁllamokNo longer taking part
- Virginia Commonwealth University Medical Center- Site Number : 8400009Richmond, Egyesült ÁllamokNo longer taking part
- University of California Davis Health- Site Number : 8400005Sacramento, Egyesült ÁllamokNo longer taking part
- University of Utah Health Hospital- Site Number : 8400026Salt Lake City, Egyesült ÁllamokNo longer taking part
Trial details
- Who runs it
- Sanofi
- Trial code
- NCT02859896
- Record updated
- 2026. július 2.
- Original description
Primary Objective:Read full original descriptionShow less
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
Primary Objective:
Evaluated the effect of Hectorol® capsules in reducing elevated levels of intact parathyroid hormone (iPTH).
Secondary Objectives:
* Evaluated the safety profile of Hectorol® capsules versus Rocaltrol® (calcitriol) capsules. * Determined the pharmacokinetic profile of 1,25-dihydroxyvitamin D2 after administration of Hectorol®.
Inclusion: 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/1.73m\^2 (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.
Exclusion: The participant used cinacalcet or vitamin D sterol therapies such as calcitriol, doxercalciferol, or paricalcitol within 14 days prior to the baseline visit; The participant had a history of, or active, symptomatic heart disease within 12 months prior to the baseline (Week 0) visit; The participant had a chronic gastrointestinal disease (ie, malabsorption, severe chronic diarrhea, chronic ulcerative colitis, or ileostomy); The participant had an active malignancy; The participant had a history of sensitivity or allergy to doxercalciferol, calcitriol or other vitamin D analogs; The participant had a serum 25-hydroxyvitamin D level <30 ng/mL at screening; The participant had a corrected calcium ≥10 mg/dL at the Week -2 visit; The participant had 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 participant used aluminum or magnesium-based binders; The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial; The participant was anticipated to require maintenance hemodialysis within 3 months; The participant had primary hyperparathyroidism or has had a total parathyroidectomy; The participant was unable to swallow a capsule in size similar to the Hectorol® and Rocaltrol® capsules.