A Phase 1 interventional study of CTAP101 Capsules and CTAP101 Injection in Chronic Kidney Disease, Secondary Hyperparathyroidism and Chronic Renal Insufficiency, sponsored by OPKO IP Holdings II, Inc.. Completed at 12 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-09-30.
Sponsored by OPKO IP Holdings II, Inc. · Phase 1, Interventional, and Treatment
This study will investigate how the levels of a single 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 Stage 3 or 4 chronic kidney disease (CKD) with vitamin D insufficiency and secondary hyperparathyroidism (SHPT).
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 28 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →OPKO IP Holdings II, Inc. is the lead sponsor of 5 studies on the registry; none are open to participants now.
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Exclusion Criteria:
CTAP101 Capsules, 450 mcg dose
Drug: CTAP101 Capsules
CTAP101 Capsules, 900 mcg dose
Drug: CTAP101 Capsules
IV injection, 448 mcg dose
Drug: CTAP101 Injection
Single dose oral administration
single IV injection
To assess the PK and bioavailability of CTAP101 in Stage 3 and 4 CKD subjects with vitamin D insufficiency and SHPT
Time frame: from 3 to 0 hours prior to dosing until 42 days post dosing
To assess the safety and tolerability of CTAP101 capsules and injection
Time frame: From signing of ICF (Day -35) through study completion (Day 42 post dosing)
To assess the pharmacodynamics of single dose CTAP101 in Stage 3 and Stage 4 CKD subjects with vitamin D insufficiency and SHPT.
Time frame: From signing of ICF (Day -35) through study completion (Day 42 post dosing)
This study is completed, as verified in Feb 2010. You cannot join it, but the record below documents what was studied.
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OPKO IP Holdings II, Inc.