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
Latest Information Update: 29 Jul 2024
At a glance
- Drugs Calcifediol (Primary)
- Indications Secondary hyperparathyroidism
- Focus Adverse reactions; Pharmacokinetics; Registrational; Therapeutic Use
- Sponsors OPKO Health
- 25 Jul 2024 Status changed from recruiting to discontinued as FDA changed the post-marketing requirement necessitating a new study design and protocol
- 22 Feb 2023 Status changed from not yet recruiting to recruiting.
- 14 Nov 2022 Planned initiation date changed from 1 Oct 2022 to 1 Dec 2022.