Comparison of I.V. CTAP201 and Doxercalciferol (Hectorol) in Subjects With Chronic Kidney Disease (CKD) and Secondary Hyperparathyroidism (SHPT)

Completed · Phase 1

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

In brief

This study will compare CTAP201 with Doxercalciferol in patients with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT), undergoing regular hemodialysis, at different dose strengths. This study will also investigate the levels of CTAP201 in the body over time and determine the safety of CTAP201.

Key facts

Study ID

NCT00792857

Run by

OPKO IP Holdings II, Inc.

People needed

24

Starts

2008-11-01

Expected to finish

2009-10-01

Last updated by the study team

2014-09-29

Who can join

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

You may qualify if…

• Body mass index between 18 and 40
• On maintenance hemodialysis three times per week
• Visit 1: Serum iPTH value greater than or equal to 200 pg/mL and lower than or equal to 1000 pg/mL
• Visit 1: Serum total calcium value greater than 8.4 mg/dL and lower than 10.0 mg/dL
• Visit 1: 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 or equal to 15 ng/mL
• Visit 2: Serum iPTH value greater than 300 pg/mL
• Visit 2: Serum Ca x P product less than 56 [mg/dl]2
• Willing and able to discontinue vitamin D and/or bone metabolism therapy for at least 2 weeks prior to administration of Study Drug, and length of study

You may not qualify if…

• Taking cytochrome P450 3A inhibitors and/or inducers
• Abnormal liver functions

Where it is running

• Pivotal Reseach Centers — Peoria, Arizona, United States
• Western New England Renal and Transplant Associates — Springfield, Massachusetts, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• Northeast Clinical Research — Allentown, Pennsylvania, United States
• Vanderbilt University — Nashville, Tennessee, United States
• Southwest Houston Research Ltd. — Houston, Texas, United States

Full record on ClinicalTrials.gov

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