Spots Global Cancer Trial Database for Safety and Efficacy of Hectorol in Pediatric Patients With Chronic Kidney Disease Stage 3 and 4 With Secondary Hyperparathyroidism Not Yet on Dialysis
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Trial Identification
Brief Title: 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 ID: NCT02859896
Study Description
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.
Keywords
Eligibility
Minimum Age: 5 Years
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Investigational Site Number :8400022, Birmingham, Alabama, United States
Investigational Site Number :8400023, Los Angeles, California, United States
Investigational Site Number :8400033, Los Angeles, California, United States
Investigational Site Number :8400005, Sacramento, California, United States
Investigational Site Number :8400029, New Haven, Connecticut, United States
Investigational Site Number :8400006, Miami, Florida, United States
Investigational Site Number :8400008, Miami, Florida, United States
Investigational Site Number :8400020, Chicago, Illinois, United States
Investigational Site Number :8400036, Indianapolis, Indiana, United States
Investigational Site Number :8400014, Minneapolis, Minnesota, United States
Investigational Site Number :8400015, Jackson, Mississippi, 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 :8400021, Syracuse, New York, United States
Investigational Site Number :8400034, Durham, North Carolina, United States
Investigational Site Number :8400025, Greenville, North Carolina, United States
Investigational Site Number :8400004, Portland, Oregon, United States
Investigational Site Number :8400035, Portland, Oregon, United States
Investigational Site Number :8400028, Pittsburgh, Pennsylvania, United States
Investigational Site Number :8400027, Greenville, South Carolina, United States
Investigational Site Number :8400024, Nashville, Tennessee, United States
Investigational Site Number :8400013, Houston, Texas, United States
Investigational Site Number :8400019, Houston, Texas, United States
Investigational Site Number :8400026, Salt Lake City, Utah, United States
Investigational Site Number :8400009, Richmond, Virginia, United States
Investigational Site Number :8400001, Marshfield, Wisconsin, United States
Investigational Site Number :1520004, Concepción, Biobío, Chile
Investigational Site Number :1520003, Santiago, Reg Metropolitana De Santiago, Chile
Contact Details
Name: Clinical Sciences & Operations
Affiliation: Sanofi
Role: STUDY_DIRECTOR
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