Clinical Trials Logo
  1. Home
  2. Vitamin D Deficiency
  3. NCT05543928

Phase 3 Safety and Efficacy Study of CTAP101 Extended-release Capsules in Children With Secondary Hyperparathyroidism

Vitamin d Deficiency Clinical Trial

Official title:
A Multi-Center Study to Evaluate the Efficacy, Safety and Pharmacokinetics of CTAP101 Extended-release Capsules to Treat Secondary Hyperparathyroidism in Pediatric Subjects of Ages 8 to <18 Years With Stage 3 or 4 Chronic Kidney Disease and Vitamin D Insufficiency

Clinical Trial Summary

This is a phase 3, multi-center, randomized, double-blind, placebo-controlled study in children with stage 3-4 chronic kidney disease (CKD), secondary hyperparathyroidism (SHPT) and vitamin D insufficiency.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05543928
Study type Interventional
Source OPKO Health, Inc.
Contact Christina Gomes
Phone 747-888-3011
Email cgomes@opko.com
Status Recruiting
Phase Phase 3
Start date January 31, 2023
Completion date July 2025
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04244474 - Effect of Vitamin D Supplementation on Improvement of Pneumonic Children Phase 1/Phase 2
Recruiting NCT05459298 - ViDES Trial (Vitamin D Extra Supplementation) N/A
Completed NCT04476511 - The Efficacy and the Safety of Vitamin D3 30,000 IU for Loading Dose Schedules Phase 3
Suspended NCT03652987 - Endocrine and Menstrual Disturbances in Women With Polycystic Ovary Syndrome (PCOS)
Completed NCT03920150 - Vitamin D 24'000 IU for Oral Intermittent Supplementation Phase 3
Completed NCT03264625 - The Effects of Oral Vitamin D Supplementation on the Prevention of Peritoneal Dialysis-related Peritonitis Phase 2
Completed NCT04183257 - Effect of Escalating Oral Vitamin D Replacement on HOMA-IR in Vitamin D Deficient Type 2 Diabetics Phase 4
Recruiting NCT05084248 - Vitamin D Deficiency in Adults Following a Major Burn Injury Phase 4
Completed NCT05506696 - Vitamin D Supplementation Study N/A
Completed NCT00092066 - A Study to Evaluate the Safety, Tolerability, and Efficacy of an Investigational Drug and Dietary Supplement in Men and Postmenopausal Women With Osteoporosis (0217A-227) Phase 3
Completed NCT03234218 - Vitamin D Levels in Liver Transplantation Recipients Prospective Observational Study
Completed NCT02906319 - Vitamin D and HbA1c Levels in Diabetic Patients With CKD N/A
Completed NCT03203382 - Corneal Nerve Structure in Sjogren's
Completed NCT02714361 - A Study to Investigate the Effect of Vitamin D3 Supplementation on Iron Status in Iron Deficient Women N/A
Completed NCT02118129 - Vitamin D Among Young Adults: an Intervention Study Using a Mobile 'App'. N/A
Not yet recruiting NCT01419821 - Vitamin D and Its Affect on Growth Rates and Bone Mineral Density Until Age 5 N/A
Completed NCT02187146 - The Effects of Serum Vitamin D and IVF Outcome N/A
Completed NCT02275650 - The Role of Narrowband Ultraviolet B Exposure in the Maintenance of Vitamin D Levels During Winter N/A
Completed NCT01688102 - The Effect of Oral Vitamin D Versus Narrow-Band UV-B Exposure on the Lipid Profile N/A
Completed NCT01651000 - Safety and Efficacy of CTAP101 to Treat Secondary Hyperparathyroidism in Stage 3 or 4 CKD and Vitamin D Insufficiency Phase 3