Spots Global Cancer Trial Database for Safety/Efficacy Study of CTAP101 in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism (SHPT)
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Trial Identification
Brief Title: Safety/Efficacy Study of CTAP101 in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism (SHPT)
Official Title: A Randomized, Double Blind, Placebo-Controlled, Repeat Dose, Safety, Efficacy and Pharmacokinetic/Pharmacodynamic Study of CTAP101 Capsules in Subjects With Chronic Kidney Disease, Vitamin D Insufficiency and Secondary Hyperparathyroidism
Study ID: NCT01219855
Study Description
Brief Summary: This study will investigate how the levels of a repeat 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 chronic kidney disease (CKD, vitamin D insufficiency and secondary hyperparathyroidism (SHPT).
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
OPKO Health, Inc, Bannockburn, Illinois, United States
Contact Details
Name: Joel Melnick, MD
Affiliation: OPKO Health, Inc.
Role: STUDY_DIRECTOR
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