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Clinical Trial Details

Trial ID: L0697
Source ID: NCT02859896
Associated Drug: Doxercalciferol (Gz427397)
Title: Safety and Efficacy of Hectorol in Pediatric Patients With Chronic Kidney Disease Stage 3 and 4 With Secondary Hyperparathyroidism Not Yet on Dialysis
Acronym:
Status: ACTIVE_NOT_RECRUITING
Study Results: NO
Results:
Conditions: Secondary Hyperparathyroidism-Chronic Kidney Disease
Interventions: DRUG: Doxercalciferol (GZ427397)|DRUG: Calcitriol
Outcome Measures: Primary: Percentage of participants achieving two consecutive ≥30% reductions in iPTH, Baseline up to Week 12 | Secondary: 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|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
Sponsor/Collaborators: Sponsor: Sanofi
Gender: ALL
Age: CHILD, ADULT
Phases: PHASE3
Enrollment: 84
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2017-01-19
Completion Date: 2025-11-12
Results First Posted:
Last Update Posted: 2023-04-27
Locations: Investigational Site Number :8400022, Birmingham, Alabama, 35233, United States|Investigational Site Number :8400023, Los Angeles, California, 90027, United States|Investigational Site Number :8400033, Los Angeles, California, 90048, United States|Investigational Site Number :8400005, Sacramento, California, 95817, United States|Investigational Site Number :8400029, New Haven, Connecticut, 06520-8017, United States|Investigational Site Number :8400006, Miami, Florida, 33101, United States|Investigational Site Number :8400008, Miami, Florida, 33155, United States|Investigational Site Number :8400020, Chicago, Illinois, 60612, United States|Investigational Site Number :8400036, Indianapolis, Indiana, 46202, United States|Investigational Site Number :8400014, Minneapolis, Minnesota, 55454, United States|Investigational Site Number :8400015, Jackson, Mississippi, 39216, United States|Investigational Site Number :8400010, Hackensack, New Jersey, 07601, United States|Investigational Site Number :8400016, Morristown, New Jersey, 07962, United States|Investigational Site Number :8400017, New Hyde Park, New York, 11040, United States|Investigational Site Number :8400007, New York, New York, 10021, United States|Investigational Site Number :8400021, Syracuse, New York, 13210, United States|Investigational Site Number :8400034, Durham, North Carolina, 27710, United States|Investigational Site Number :8400025, Greenville, North Carolina, 27834, United States|Investigational Site Number :8400004, Portland, Oregon, 97227, United States|Investigational Site Number :8400035, Portland, Oregon, 97239-3098, United States|Investigational Site Number :8400028, Pittsburgh, Pennsylvania, 15224, United States|Investigational Site Number :8400027, Greenville, South Carolina, 29605, United States|Investigational Site Number :8400024, Nashville, Tennessee, 37292, United States|Investigational Site Number :8400013, Houston, Texas, 77030, United States|Investigational Site Number :8400019, Houston, Texas, 77030, United States|Investigational Site Number :8400026, Salt Lake City, Utah, 84113, United States|Investigational Site Number :8400009, Richmond, Virginia, 23298, United States|Investigational Site Number :8400001, Marshfield, Wisconsin, 54449, United States|Investigational Site Number :1520004, Concepción, Biobío, Chile|Investigational Site Number :1520003, Santiago, Reg Metropolitana De Santiago, Chile
URL: https://clinicaltrials.gov/show/NCT02859896

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D018 Calcitriol small molecule DB00136 Details