drugset / Trial / NCT01219855
Safety/Efficacy Study of CTAP101 in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism (SHPT)
RandomizedParallel-groupTriple-blindTreatment
Summary
This study will investigate how the levels of a repeat dose of CTAP101 changes in the body over time (pharmacokinetics, PK) and how CTAP101 affects other mineral and hormonal balances (pharmacodynamics, PD) in patients with chronic kidney disease (CKD, vitamin D insufficiency and secondary hyperparathyroidism (SHPT).
Timeline
- Start
- 2010-10
- Primary completion
- 2011-11
- Completion
- 2011-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Calcifediol | Unknown | 30 ug | — |
| Subject | Calcifediol | Unknown | 60 ug | — |
| Subject | Calcifediol | Unknown | 90 ug | — |