Pharmacokinetics and Safety Pilot Study of Single-Dose Oral and Intravenous CTAP101 in Stage 3 and 4 Chronic Kidney Disease Subjects

Completed · Phase 1

Conditions studied: Chronic Kidney Disease, Secondary Hyperparathyroidism, Chronic Renal Insufficiency, Chronic Renal Failure

In brief

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).

Key facts

Study ID

NCT00888069

Run by

OPKO IP Holdings II, Inc.

People needed

28

Starts

2009-05-01

Expected to finish

2009-12-01

Last updated by the study team

2014-09-30

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Pivotal Research Centers — Peoria, Arizona, United States
• Research by Design — Evergreen Park, Illinois, United States
• Western New England Renal & Transplant Associates — Springfield, Massachusetts, United States
• Twin Cities Clinical Research — Brooklyn Center, Minnesota, United States
• DCI — Cincinnati, Ohio, United States
• MetroHealth Medical Center — Cleveland, Ohio, United States
• Northeast Clinical Research — Allentown, Pennsylvania, United States
• Southeast Renal Research Institute — Chattanooga, Tennessee, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Southwest Houston Research Ltd — Houston, Texas, United States
• Purity Dialysis Centers / Nephrology Associates — Delafield, Wisconsin, United States
• Gunderson Clinic Ltd. — La Crosse, Wisconsin, United States

Full record on ClinicalTrials.gov

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