Clinical trial NCT02859896: Safety and Efficacy of Hectorol in Pediatric Patients With Chronic Kidney Disease Stage 3 and 4 With Secondary Hyperparathyroidism Not Yet on Dialysis
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Secondary Hyperparathyroidism-Chronic Kidney Disease
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2016-08-09
Enrollment: 84
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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®.

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

Eligibility criteria: Inclusion criteria :

* 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 criteria:

* 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.

Primary outcomes:
measure: Percentage of participants achieving two consecutive ≥30% reductions in iPTH
timeFrame: Baseline up to Week 12
Secondary outcomes:
measure: Percentage change from baseline in iPTH
timeFrame: Baseline, Week 12, Week 24
measure: Number of hypercalcemia events (albumin corrected serum calcium >10.2 mg/dL)
timeFrame: Up to Weeks 12 and 24
measure: Number of participants with adverse events
timeFrame: Baseline up to Week 24
measure: Assessment of pharmacokinetic (PK) parameter: Serum 1,25-dihydroxyvitamin D2 concentration-time data
timeFrame: At Week -2, Baseline, and then within 24 hours of the most recent dose of Hectorol® at Weeks 2, 4, 6, 8 or 10 (whichever week is not used for serial PK assessment), and 12
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Investigational Site Number :8400022
state: Alabama
city: Los Angeles
country: United States
facility: Investigational Site Number :8400023
state: California
city: Los Angeles
country: United States
facility: Investigational Site Number :8400033
state: California
city: Sacramento
country: United States
facility: Investigational Site Number :8400005
state: California
city: New Haven
country: United States
facility: Investigational Site Number :8400029
state: Connecticut
city: Miami
country: United States
facility: Investigational Site Number :8400006
state: Florida
city: Miami
country: United States
facility: Investigational Site Number :8400008
state: Florida
city: Chicago
country: United States
facility: Investigational Site Number :8400020
state: Illinois
city: Indianapolis
country: United States
facility: Investigational Site Number :8400036
state: Indiana
city: Minneapolis
country: United States
facility: Investigational Site Number :8400014
state: Minnesota
city: Jackson
country: United States
facility: Investigational Site Number :8400015
state: Mississippi
city: Hackensack
country: United States
facility: Investigational Site Number :8400010
state: New Jersey
city: Morristown
country: United States
facility: Investigational Site Number :8400016
state: New Jersey
city: New Hyde Park
country: United States
facility: Investigational Site Number :8400017
state: New York
city: New York
country: United States
facility: Investigational Site Number :8400007
state: New York
city: Syracuse
country: United States
facility: Investigational Site Number :8400021
state: New York
city: Durham
country: United States
facility: Investigational Site Number :8400034
state: North Carolina
city: Greenville
country: United States
facility: Investigational Site Number :8400025
state: North Carolina
city: Portland
country: United States
facility: Investigational Site Number :8400004
state: Oregon
city: Portland
country: United States
facility: Investigational Site Number :8400035
state: Oregon
city: Pittsburgh
country: United States
facility: Investigational Site Number :8400028
state: Pennsylvania
city: Greenville
country: United States
facility: Investigational Site Number :8400027
state: South Carolina
city: Nashville
country: United States
facility: Investigational Site Number :8400024
state: Tennessee
city: Houston
country: United States
facility: Investigational Site Number :8400013
state: Texas
city: Houston
country: United States
facility: Investigational Site Number :8400019
state: Texas
city: Salt Lake City
country: United States
facility: Investigational Site Number :8400026
state: Utah
city: Richmond
country: United States
facility: Investigational Site Number :8400009
state: Virginia
city: Marshfield
country: United States
facility: Investigational Site Number :8400001
state: Wisconsin
city: Concepción
country: Chile
facility: Investigational Site Number :1520004
state: Biobío
city: Santiago
country: Chile
facility: Investigational Site Number :1520003
state: Reg Metropolitana De Santiago
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: