Safety/Efficacy Study of CTAP101 in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism (SHPT)
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
Outcome
Met primary endpoint
registry analysis (superiority or other test); Cohort 1: CTAP101 Capsules 60µg vs Cohort 1: CTAP101 Capsules 90µg vs Cohort 2: CTAP101 Capsules 30µg vs Cohort 2: Sugar Capsule; p <0.0001; Z-test cmpared 2 independ. proportions NCT01219855 ↗
registry analysis (superiority or other test); Cohort 2: CTAP101 Capsules 30µg vs Cohort 2: Sugar Capsule; p <0.01; Mixed effect model NCT01219855 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Calcifediol | Unknown | 30 ug | — |
| Subject | Calcifediol | Unknown | 60 ug | — |
| Subject | Calcifediol | Unknown | 90 ug | — |