Spots Global Cancer Trial Database for Safety, Efficacy, PK and PD of CTAP101 (Calcifediol) ER Capsules for SHPT in HD Patients VDI
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Trial Identification
Brief Title: Safety, Efficacy, PK and PD of CTAP101 (Calcifediol) ER Capsules for SHPT in HD Patients VDI
Official Title: A Multi-Center, Randomized, Two-Cohort Phase 2 Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of CTAP101 (Calcifediol) Extended-Release Capsules to Treat Secondary Hyperparathyroidism in Subjects With Vitamin D Insufficiency and Chronic Kidney Disease Requiring Regular Hemodialysis.
Study ID: NCT03602261
Study Description
Brief Summary: Safety, Efficacy, PK and PD of CTAP101 (calcifediol) ER Capsules for SHPT in HD Patients VDI
Detailed Description: A Multi-Center, Randomized, Two-Cohort Phase 2 Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of CTAP101 (calcifediol) Extended-Release Capsules to Treat Secondary Hyperparathyroidism in Subjects with Vitamin D Insufficiency and Chronic Kidney Disease Requiring Regular Hemodialysis.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
AKDHC Medical Research Services, Peoria, Arizona, United States
AKDHC Medical Research Services, Phoenix, Arizona, United States
AKDHC Medical Research Services, Phoenix, Arizona, United States
AKDHC Medical Research Services, Phoenix, Arizona, United States
WCCT Global, Inc., Cypress, California, United States
Hacienda Dialysis Center, Hacienda Heights, California, United States
California Institute of Renal Research CKD/Dialysis & Transplant Division, La Mesa, California, United States
Long Beach Quest Dialysis Center, Long Beach, California, United States
Ontario Dialysis Center, Ontario, California, United States
North America Research Institute, Inc., San Dimas, California, United States
Laurel Canyon Dialysis, LLC, Sun Valley, California, United States
University of Colorado Denver Anschutz Medical Campus, Aurora, Colorado, United States
Research by Design, LLC, Chicago, Illinois, United States
Northshore University Health, Evanston, Illinois, United States
Renal and Transplant Associates of New England, Springfield, Massachusetts, United States
Southwest MS Nephrology, McComb, Mississippi, United States
Southwest Houston Research LTD, Houston, Texas, United States
Kidney & Hypertension Specialists, San Antonio, Texas, United States
Contact Details
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