Calcifediol
- Generic Name
- Calcifediol
- Brand Names
- Rayaldee
- Drug Type
- Small Molecule
- Chemical Formula
- C27H44O2
- CAS Number
- 19356-17-3
- Unique Ingredient Identifier
- T0WXW8F54E
- Background
The major circulating metabolite of vitamin D3 (cholecalciferol). It is produced in the liver and is the best indicator of the body's vitamin D stores. It is effective in the treatment of rickets and osteomalacia, both in azotemic and non-azotemic patients. Calcifediol also has mineralizing properties.
- Indication
Used to treat vitamin D deficiency or insufficiency, refractory rickets (vitamin D resistant rickets), familial hypophosphatemia and hypoparathyroidism, and in the management of hypocalcemia and renal osteodystrophy in patients with chronic renal failure undergoing dialysis. Also used in conjunction with calcium in the management and prevention of primary or corticosteroid-induced osteoporosis.
- Associated Conditions
- Secondary Hyperparathyroidism (SHPT)
Calcifediol in the Treatment of SARS-CoV-2 Disease (COVID-19).
- First Posted Date
- 2024-02-28
- Last Posted Date
- 2024-02-28
- Lead Sponsor
- Complejo Hospitalario Universitario de Albacete
- Target Recruit Count
- 275
- Registration Number
- NCT06279910
- Locations
- 🇪🇸
Complejo Hospitalario Universitario de la Gerencia de Atención Integrada (GAI) de Albacete, Albacete, Spain
🇪🇸Maimónides Biomedical Research Institute of Córdoba (IMIBIC)., Cordoba, Spain
REstoration of VItamin D in Pulmonary Arterial Hypertension
- Conditions
- Pulmonary Artery HypertensionVitamin d Deficiency
- Interventions
- Drug: Placebo
- First Posted Date
- 2024-02-14
- Last Posted Date
- 2024-02-14
- Lead Sponsor
- Parc de Salut Mar
- Target Recruit Count
- 102
- Registration Number
- NCT06258850
Calcifediol in the Treatment of COVID 19
- First Posted Date
- 2023-04-19
- Last Posted Date
- 2023-04-28
- Lead Sponsor
- Maimónides Biomedical Research Institute of Córdoba
- Target Recruit Count
- 728
- Registration Number
- NCT05819918
- Locations
- 🇪🇸
Hospital Universitario Reina Sofia, Cordoba, Córdoba, Spain
Phase 3 Safety and Efficacy Study of CTAP101 Extended-release Capsules in Children With Secondary Hyperparathyroidism
- Conditions
- Chronic Kidney Disease stage3Chronic Kidney Disease stage4Vitamin d DeficiencySecondary Hyperparathyroidism
- Interventions
- Drug: Placebo
- First Posted Date
- 2022-09-16
- Last Posted Date
- 2024-07-25
- Lead Sponsor
- OPKO Health, Inc.
- Target Recruit Count
- 2
- Registration Number
- NCT05543928
- Locations
- 🇺🇸
Nationwide Childrens Hospital, Columbus, Ohio, United States
Efficacy and Safety of Calcifediol vs Placebo in Subjects With Vitamin D Deficiency
- Conditions
- Vitamin D DeficiencyVitamin D Insufficiency
- Interventions
- First Posted Date
- 2021-02-03
- Last Posted Date
- 2023-09-15
- Lead Sponsor
- Faes Farma, S.A.
- Target Recruit Count
- 674
- Registration Number
- NCT04735926
- Locations
- 🇸🇰
KK Neuro, s.r.o., Neurologická ambulancia, Žilina, Slovakia
🇪🇸Hospital Universitario Rio Hortega, Valladolid, Spain
🇪🇸Hospital Quirónsalud Barcelona, Barcelona, Spain
Safety and Efficacy of Rayaldee for Treating Mild to Moderate COVID-19
- Conditions
- CoronavirusSARS-CoV2 InfectionCOVID-19
- Interventions
- Drug: Placebo
- First Posted Date
- 2020-09-16
- Last Posted Date
- 2024-05-28
- Lead Sponsor
- OPKO Health, Inc.
- Target Recruit Count
- 171
- Registration Number
- NCT04551911
- Locations
- 🇺🇸
OPKO Investigative Site, Omaha, Nebraska, United States
Safety, Efficacy, PK and PD of CTAP101 (Calcifediol) ER Capsules for SHPT in HD Patients VDI
- Conditions
- Chronic Kidney DiseasesSecondary Hyperparathyroidism Due to Renal CausesStage 5 Chronic Kidney DiseaseVitamin D Deficiency
- Interventions
- Drug: Placebo oral capsule
- First Posted Date
- 2018-07-26
- Last Posted Date
- 2025-03-30
- Lead Sponsor
- OPKO Health, Inc.
- Target Recruit Count
- 44
- Registration Number
- NCT03602261
- Locations
- 🇺🇸
Research by Design, LLC, Chicago, Illinois, United States
🇺🇸Northshore University Health, Evanston, Illinois, United States
🇺🇸Southwest Houston Research LTD, Houston, Texas, United States
Repeated-dose Safety, Efficacy, Pharmacokinetic and Pharmacodynamic of CTAP101, Immediate-release Calcifediol, High-dose Cholecalciferol, and Paricalcitol Plus Low-dose Cholecalciferol in Patients With Secondary Hyperparathyroidism, Chronic Kidney Disease 3-4 and Vitamin D Insufficiency
- Conditions
- Secondary Hyperparathyroidism Due to Renal CausesVitamin D InsufficiencyCKD Stage 3CKD Stage 4
- Interventions
- First Posted Date
- 2018-07-17
- Last Posted Date
- 2022-12-09
- Lead Sponsor
- OPKO Health, Inc.
- Target Recruit Count
- 69
- Registration Number
- NCT03588884
- Locations
- 🇺🇸
Research by Design, LLC, Chicago, Illinois, United States
🇺🇸National Institute of Clinical Research, Inc., Garden Grove, California, United States
🇺🇸Spaulding Clinical Research, West Bend, Wisconsin, United States
25-Hydroxyvitamin D Pharmacokinetic Study
- Conditions
- Vitamin D DeficiencyFat Malabsorption
- Interventions
- First Posted Date
- 2018-01-17
- Last Posted Date
- 2020-06-04
- Lead Sponsor
- Boston University
- Target Recruit Count
- 16
- Registration Number
- NCT03401541
- Locations
- 🇺🇸
Solomon Carter Fuller Mental Health Center, Boston, Massachusetts, United States
The Effect of Supplementation of Vitamin D Deficiency in Older People With Acute Hip Fracture:
- Conditions
- Hip FractureVitamin D Deficiency
- Interventions
- First Posted Date
- 2017-07-11
- Last Posted Date
- 2021-02-02
- Lead Sponsor
- Leonor Cuadra Llopart
- Target Recruit Count
- 50
- Registration Number
- NCT03213886
- Locations
- 🇪🇸
Consorci Sanitari de Terrassa, Terrassa, Barcelona, Spain
Drug Development Updates
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