Status:
COMPLETED
Safety/Efficacy Study of CTAP101 in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism (SHPT)
Lead Sponsor:
OPKO Health, Inc.
Conditions:
Chronic Kidney Disease
Secondary Hyperparathyroidism
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
PHASE3
Brief 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 (pharmacodynamic...
Eligibility Criteria
Inclusion
- Urinary albumin excretion of ≤3000 μg of creatinine
- Stage 3 CKD
- Plasma iPTH: \> 70 pg/mL and \< 500 pg/mL
- Serum Ca: ≥ 8.4 mg/dL and \< 10.0 mg/dL
- Serum P: ≥ 2.0 mg/dL and \< 5.0 mg/dL
- Serum 25-hydroxyvitamin D: \> 10 ng/mL and \< 29 ng/mL.
- Discontinue vitamin D use for duration of study
Exclusion
- History of kidney transplant or parathyroidectomy
- Spot urine calcium:creatinine ratio \> 0.2
- Current serious illness, such as malignancy, HIV, liver disease, cardiovascular event or hepatitis
- Currently on dialysis
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT01219855
Start Date
October 1 2010
End Date
November 1 2011
Last Update
August 25 2016
Active Locations (1)
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1
OPKO Health, Inc
Bannockburn, Illinois, United States, 60015