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: |
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La Crosse |
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State:
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WI |
| Zip Code: |
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54601 |
| Conditions: |
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Chronic Kidney Disease - Secondary Hyperparathyroidism - Chronic Renal Insufficiency - Chronic Renal Failure |
| Purpose: |
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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).
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| Study summary: |
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| Criteria: |
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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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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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February 17, 2010 |
Modifications to
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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