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Pharmacokinetics and Safety Pilot Study of Single-Dose Oral and Intravenous CTAP101 in Stage 3 and 4 Chronic Kidney Disease Subjects - NCT00888069-54601(Clinical Trial 349789)



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City:  La Crosse
State:  
WI
Zip Code: 54601
Conditions: Chronic Kidney Disease - Secondary Hyperparathyroidism - Chronic Renal Insufficiency - Chronic Renal Failure
Purpose: 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).
Study summary:
Criteria: Inclusion Criteria: - 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 Criteria: - 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
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Data Source: ClinicalTrials.gov
Date Processed: February 17, 2010
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