NCT03602261Phase 2Terminated

Safety, Efficacy, PK and PD of CTAP101 (Calcifediol) ER Capsules for SHPT in HD Patients VDI

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2021-02-24Actual

Enrollment · participants44Actual

Source updated2026-04-03Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Study details

Conditions studied

Secondary Hyperparathyroidism Due to Renal Causes; Chronic Kidney Diseases; Vitamin D Deficiency; Stage 5 Chronic Kidney Disease

Treatments or interventions studied

Calcifediol Oral CapsuleDrugAlso known as CTAP101
Placebo oral capsuleDrug

Primary outcomes · main study measures

Read the study measures

measure: Number of Participants With Response During Efficacy Assessment Period; description: 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.; timeFrame: 26 weeks; measure: Total 25-hydroxyvitamin D Response Analysis During Efficacy Period; description: Summary of participants with mean serum total 25-hydroxyvitamin D ≥50 ng/mL at the end of treatment; timeFrame: 26 weeks; measure: Number of Participants With Intact Parathyroid Hormone (iPTH) Response During Efficacy Assessment Period; description: Summary of participants who experienced a reduction in mean plasma iPTH by greater than 30% from the pre-treatment baseline; timeFrame: 26 weeks; measure: Pharmacokinetic (PK) Profile (Cmax) of Serum Calcifediol; description: 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); timeFrame: 0, 4, 8, 12, 16, 20, 24, 30, 36, 42 and 48 hours post-dose (single and repeat dose); measure: Pharmacokinetic (PK) Profile (Tmax) of Serum Calcifediol; description: 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); timeFrame: 0, 4, 8, 12, 16, 20, 24, 30, 36, 42 and 48 hours post-dose (single and repeat dose); measure: Pharmacokinetic (PK) Profile (AUC0-t) of Serum Calcifediol; description: 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); timeFrame: 0, 4, 8, 12, 16, 20, 24, 30, 36, 42 and 48 hours post-dose (single and repeat dose)

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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