Safety and Efficacy of Hectorol in Pediatric Patients With Chronic Kidney Disease Stage 3 and 4 With Secondary Hyperparathyroidism Not Yet on Dialysis
- Conditions
- Secondary Hyperparathyroidism-Chronic Kidney Disease
- Interventions
- Registration Number
- NCT02859896
- Lead Sponsor
- Sanofi
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 84
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Hectorol Doxercalciferol (GZ427397) Hectorol (Doxercalciferol) will be administered orally two to three times weekly dependent on patient age. A dose titration scheme is used to individualize the dose to the patient's iPTH management. Rocaltrol Calcitriol Rocaltrol (Calcitriol) will be administered orally seven days/week. A dose titration scheme is used to individualize the dose to the patient's iPTH management.
- Primary Outcome Measures
Name Time Method Percentage of participants achieving two consecutive ≥30% reductions in iPTH Baseline up to Week 12
- Secondary Outcome Measures
Name Time Method Assessment of pharmacokinetic (PK) parameter: Serum 1,25-dihydroxyvitamin D2 concentration-time data 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 Percentage change from baseline in iPTH Baseline, Week 12, Week 24 Number of hypercalcemia events (albumin corrected serum calcium >10.2 mg/dL) Up to Weeks 12 and 24 Number of participants with adverse events Baseline up to Week 24
Trial Locations
- Locations (30)
Investigational Site Number :8400025
🇺🇸Greenville, North Carolina, United States
Investigational Site Number :8400015
🇺🇸Jackson, Mississippi, United States
Investigational Site Number :8400021
🇺🇸Syracuse, New York, United States
Investigational Site Number :8400001
🇺🇸Marshfield, Wisconsin, United States
Investigational Site Number :8400020
🇺🇸Chicago, Illinois, United States
Investigational Site Number :8400028
🇺🇸Pittsburgh, Pennsylvania, United States
Investigational Site Number :8400006
🇺🇸Miami, Florida, United States
Investigational Site Number :8400008
🇺🇸Miami, Florida, United States
Investigational Site Number :8400036
🇺🇸Indianapolis, Indiana, United States
Investigational Site Number :8400014
🇺🇸Minneapolis, Minnesota, United States
Investigational Site Number :8400034
🇺🇸Durham, North Carolina, United States
Investigational Site Number :8400024
🇺🇸Nashville, Tennessee, United States
Investigational Site Number :8400026
🇺🇸Salt Lake City, Utah, United States
Investigational Site Number :8400013
🇺🇸Houston, Texas, United States
Investigational Site Number :8400019
🇺🇸Houston, Texas, United States
Investigational Site Number :8400022
🇺🇸Birmingham, Alabama, United States
Investigational Site Number :8400004
🇺🇸Portland, Oregon, United States
Investigational Site Number :8400035
🇺🇸Portland, Oregon, United States
Investigational Site Number :8400023
🇺🇸Los Angeles, California, United States
Investigational Site Number :8400033
🇺🇸Los Angeles, California, United States
Investigational Site Number :8400029
🇺🇸New Haven, Connecticut, United States
Investigational Site Number :8400005
🇺🇸Sacramento, California, United States
Investigational Site Number :8400010
🇺🇸Hackensack, New Jersey, United States
Investigational Site Number :8400016
🇺🇸Morristown, New Jersey, United States
Investigational Site Number :8400017
🇺🇸New Hyde Park, New York, United States
Investigational Site Number :8400007
🇺🇸New York, New York, United States
Investigational Site Number :8400027
🇺🇸Greenville, South Carolina, United States
Investigational Site Number :1520003
🇨🇱Santiago, Reg Metropolitana De Santiago, Chile
Investigational Site Number :1520004
🇨🇱Concepción, Biobío, Chile
Investigational Site Number :8400009
🇺🇸Richmond, Virginia, United States