| Outcome Measures: |
Primary: Number of Participants With Response During Efficacy Assessment Period, To evaluate the efficacy of repeated dosing with 900 mcg per week of CTAP101 extended release (ER) Capsules versus placebo in raising mean serum total 25-hydroxyvitamin D (25D) to ≥50 ng/mL and in reducing mean plasma intact parathyroid hormone (iPTH) by at least 30% from pre-treatment baseline., 26 weeks|Total 25-hydroxyvitamin D Response Analysis During Efficacy Period, Summary of participants with mean serum total 25-hydroxyvitamin D ≥50 ng/mL at the end of treatment, 26 weeks|Number of Participants With Intact Parathyroid Hormone (iPTH) Response During Efficacy Assessment Period, Summary of participants who experienced a reduction in mean plasma iPTH by greater than 30% from the pre-treatment baseline, 26 weeks|Pharmacokinetic (PK) Profile (Cmax) of Serum Calcifediol, To assess Cmax of serum calcifediol after a single dose of 900 mcg at the start of the study (Single Dose PK Period), and a repeat dose of 300 mcg at the end of the study (Repeat Dose PK Period), 0, 4, 8, 12, 16, 20, 24, 30, 36, 42 and 48 hours post-dose (single and repeat dose)|Pharmacokinetic (PK) Profile (Tmax) of Serum Calcifediol, To assess Tmax of serum calcifediol after a single dose of 900 mcg at the start of the study (Single Dose PK Period), and a repeat dose of 300 mcg at the end of the study (Repeat Dose PK Period), 0, 4, 8, 12, 16, 20, 24, 30, 36, 42 and 48 hours post-dose (single and repeat dose)|Pharmacokinetic (PK) Profile (AUC0-t) of Serum Calcifediol, To assess AUC0-t of serum calcifediol after a single dose of 900 mcg at the start of the study (Single Dose PK Period), and a repeat dose of 300 mcg at the end of the study (Repeat Dose PK Period), 0, 4, 8, 12, 16, 20, 24, 30, 36, 42 and 48 hours post-dose (single and repeat dose) | Secondary: Pharmacodynamic Analysis of 1,25-dihydroxyvitamin D, Effect of CTAP101 on 1,25-dihydroxyvitamin D, 26 weeks
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| Locations: |
AKDHC Medical Research Services, Peoria, Arizona, 85381, United States|AKDHC Medical Research Services, Phoenix, Arizona, 85027, United States|AKDHC Medical Research Services, Phoenix, Arizona, 85035, United States|AKDHC Medical Research Services, Phoenix, Arizona, 85258, United States|WCCT Global, Inc., Cypress, California, 90630, United States|Hacienda Dialysis Center, Hacienda Heights, California, 91745, United States|California Institute of Renal Research CKD/Dialysis & Transplant Division, La Mesa, California, 91942, United States|Long Beach Quest Dialysis Center, Long Beach, California, 90807, United States|Ontario Dialysis Center, Ontario, California, 91762, United States|North America Research Institute, Inc., San Dimas, California, 91773, United States|Laurel Canyon Dialysis, LLC, Sun Valley, California, 91352, United States|University of Colorado Denver Anschutz Medical Campus, Aurora, Colorado, 80045, United States|Research by Design, LLC, Chicago, Illinois, 60643, United States|Northshore University Health, Evanston, Illinois, 60201, United States|Renal and Transplant Associates of New England, Springfield, Massachusetts, 01107, United States|Southwest MS Nephrology, McComb, Mississippi, 39601, United States|Southwest Houston Research LTD, Houston, Texas, 77099, United States|Kidney & Hypertension Specialists, San Antonio, Texas, 78207, United States
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