About the study

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

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria

1. cinacalcet) and/or calcitriol or other 1α-hydroxylated vitamin D analog (paricalcitol or
2. doxercalciferol) for at least 1 month at the time of screening for enrollment. At least 50% of enrolled subjects will have been receiving calcimimetic therapy. - Exhibit during the initial screening visit: - Plasma iPTH ≥150 pg/mL and <600 pg/mL if receiving etelcalcetide, cinacalcet, calcitriol or other 1α-hydroxylated vitamin D analog (paricalcitol or doxercalciferol); or - Plasma iPTH ≥300 pg/mL and <900 pg/mL if not receiving etelcalcetide, cinacalcet, calcitriol or other 1α-hydroxylated vitamin D analog; and, - Serum total 25-hydroxyvitamin D <30 ng/mL if not receiving vitamin D supplementation. - When otherwise confirmed eligible at Visit 1, must forgo any further treatment with etelcalcetide and cinacalcet for the duration of the study and undergo an 8-week washout period. - When otherwise confirmed eligible at Visit 1, must forgo any further treatment with calcitriol or other 1α-hydroxylated vitamin D analogs or vitamin D supplements for the duration of the study and undergo an 8-week washout period. - Exhibit after the 8-week washout period (if required due to prior use of etelcalcetide, cinacalcet, calcitriol or other 1α-hydroxylated vitamin D analogs, or vitamin D supplementation): Cohort 1: - Plasma iPTH increased by at least 50%; and, - Plasma iPTH ≥300 pg/mL and <1,200 pg/mL; or, Cohort 2: a. Plasma iPTH ≥300 pg/mL and <1,200 pg/mL (approximately half of the subjects will be enrolled in each of these two iPTH strata: ≥300 to <600 and ≥600 to <1,200 pg/mL); and Cohorts 1 and 2: - Corrected serum calcium <9.8 mg/dL; - Serum total 25-hydroxyvitamin D <30 ng/mL; and, - Serum phosphorus <6.5 mg/dL. - When otherwise confirmed eligible at Visit 1, if taking more than 1,000 mg per day of elemental calcium, reduce calcium use (to ≤1,000 mg per
3. day) and/or use non-calcium based phosphate binder therapies (as
4. needed) for the duration of the study. - When otherwise confirmed eligible at Visit 1, if taking bone metabolism therapies that may interfere with study endpoints, must discontinue use of these agents for the duration of the study. - Willing and able to comply with study instructions and commit to all clinic visits for the duration of the study. - Female subjects of childbearing potential must be neither pregnant nor lactating and must have a negative serum beta-human chorionic gonadotropin (b-
5. hCG) pregnancy test at the first screening visit and at other scheduled times. - All female subjects of childbearing potential and male subjects with female partners of childbearing potential must agree to use effective contraception (eg, implants, injectables, combined oral contraceptives, intrauterine device, sexual abstinence, vasectomy or vasectomized
6. partner) for the duration of the study. - Be able to read, understand and sign the subject Informed Consent Form (
7. ICF) or have a legal representative sign the ICF. 4.3

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

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