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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

Useful links and downloads for this trial

Clinicaltrials.gov

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