Status:
COMPLETED
Pharmacokinetics and Safety Pilot Study of Single-Dose Oral and Intravenous CTAP101 in Stage 3 and 4 Chronic Kidney Disease Subjects
Lead Sponsor:
OPKO IP Holdings II, Inc.
Conditions:
Chronic Kidney Disease
Secondary Hyperparathyroidism
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief Summary
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 (pharmacodynamic...
Eligibility Criteria
Inclusion
- Body mass index between great than or equal to 18 and less than or equal to 40 kg/m2
- Plasma iPTH value for Stage 3 CKD greater than or equal to 70 pg/mL and lower than or equal to 1000 pg/mL
- Plasma iPTH value for Stage 4 CKD greater than or equal to 110 pg/mL and lower than or equal to 1000 pg/mL
- Adjusted serum total calcium value greater than 8.4 mg/dL and lower than 10.0 mg/dL
- Serum phosphorus value greater than or equal to 2.5 mg/dL and lower than or equal to 5.5 mg/dL
- Serum 25-hydroxyvitamin D level greater than 15 ng/mL and lower than 30 ng/mL
- Hemoglobin level greater than or equal to 10 g/dL
Exclusion
- Has nephrotic range proteinuria
- Has liver disease or significant hepatic dysfunction
- Is taking Cytochrome P450 3A4 inhibitors or inducers
- Has adult history of kidney stones and dysphagia
- Has known history of alcohol/controlled substance abuse or are positive for drug of abuse screen
- Currently on dialysis
- Current serious illness such as cancer, HIV, cardiovascular event or hepatitis
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00888069
Start Date
May 1 2009
End Date
December 1 2009
Last Update
September 30 2014
Active Locations (12)
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1
Pivotal Research Centers
Peoria, Arizona, United States, 85381
2
Research by Design
Evergreen Park, Illinois, United States, 60805
3
Western New England Renal & Transplant Associates
Springfield, Massachusetts, United States, 01107
4
Twin Cities Clinical Research
Brooklyn Center, Minnesota, United States, 55430