Safety and Efficacy of Hectorol in Pediatric Patients With Chronic Kidney Disease Stage 3 and 4 W… (NCT02859896) | Clinical Trial Compass
TerminatedPhase 3
Safety and Efficacy of Hectorol in Pediatric Patients With Chronic Kidney Disease Stage 3 and 4 With Secondary Hyperparathyroidism Not Yet on Dialysis
Stopped: The study was conducted to fulfill a post-marketing commitment (PMC).FDA acknowledged the fulfillment of this PMC.
United States21 participantsStarted 2017-01-19
Plain-language 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®.
Who can participate
Age range5 Years – 18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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® capsul…
What they're measuring
1
Percentage of participants achieving two consecutive ≥30% reductions in iPTH