drugset / Trial / NCT03588884
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
RandomizedParallel-groupOpen-labelTreatment
Summary
An Open-Label, Repeated-Dose Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Study of Oral CTAP101 Capsules, Immediate- Release (IR) Calcifediol, High-Dose Cholecalciferol, and Paricalcitol Plus Low-Dose Cholecalciferol in Patients with Secondary Hyperparathyroidism, Stage 3 or 4 Chronic Kidney Disease and Vitamin D Insufficiency
Timeline
- Start
- 2018-06-08
- Primary completion
- 2020-04-24
- Completion
- 2020-04-24
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Calcifediol | Unknown | 60 ug | Oral |
| Comparator | Calcifediol | Unknown | 266 ug | Oral |
| Subject | Cholecalciferol | Other / unclassified | 800 iu | Oral |
| Subject | Cholecalciferol | Other / unclassified | 300000 iu | Oral |
| Comparator | Paricalcitol | Other / unclassified | 1 ug | Oral |