Extension Study of CTAP101-CL-3001 or CTAP101-CL-3002
Condition: Chronic Kidney Disease; Hyperparathyroidism, Secondary; Vitamin D Deficiency
MeSH terms: Neoplasm Metastasis; Kidney Diseases; Renal Insufficiency, Chronic; Vitamin D Deficiency; Hyperparathyroidism; Hyperparathyroidism, Secondary
Intervention: CTAP101 Capsules; Calcitriol; Doxercalciferol; Paricalcitol
Intervention description: At week 12, eligible subjects will continue to take 1-2 capsules (30 mcg each capsule) CTAP101 daily; At week 12, eligible subjects will be randomized to also take calcitriol 0.25 mcg dose one capsule daily; At week 12, eligible subjects will be randomized to also take doxercalciferol 0.5 mcg one capsule daily; At week 12, eligible subjects will be randomized to also take paricalcitol 1 mcg one capsule daily
Intervention MeSH terms: Calcitriol; Calcifediol; 1 alpha-hydroxyergocalciferol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 298.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Parathyroid Diseases; Renal Insufficiency; Kidney Failure, Chronic; Hyperparathyroidism, Secondary; Vitamin D; Hyperparathyroidism; Kidney Diseases; Kidney Failure; Renal Insufficiency, Chronic

Summary:

      This extension study of subjects previously enrolled in studies CTAP101-CL-3001 or
      CTAP101-CL-3002 allows long term evaluation of the safety and efficacy of CTAP101 Capsules in
      reducing elevated intact parathyroid hormone (iPTH) and correcting vitamin D insufficiency in
      stage 3 or 4 chronic kidney disease patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completed either of the phase 3 double-blind, placebo-controlled studies,
             CTAP101-CL-3001 or CTAP101-CL-3002

          -  Taking no more than 1000 mg/day of elemental Ca and willing/able to remain on this
             dose for the duration of the study

          -  Taking no more than 1600 IU/dose vitamin D (ergocalciferol or cholecalciferol) therapy
             and willing/able to remain on a stable dose of vitamin D during the study

          -  Willing and able to comply with study instructions and to 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 urine pregnancy test

          -  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 partner) for the duration of the study

          -  Have the ability to read and understand subject Informed Consent Form (ICF). Subjects
             or their legal representatives must sign the ICF.

        Exclusion Criteria:

          -  Use of pharmacological dose of ergocalciferol and cholecalciferol (monthly equivalent
             of 50,000 IU or 1250 µg, eg, Drisdol®) or bisphosphonate therapy

          -  Use of other bone metabolism therapy (with the exception of stable doses of
             bisphosphonates and denosumab [Xgeva® and Prolia®]) that may interfere with study
             endpoints

          -  Concomitant serious illness or medical condition, such as malignancy, human
             immunodeficiency virus, significant gastrointestinal or hepatic disease or
             cardiovascular event or hepatitis that in the opinion of the investigator may worsen
             and/or interfere with participation in the study

          -  Neurological/psychiatric disorder, including psychotic disorder or dementia, or any
             condition reason which, in the opinion of the investigator makes adherence to a
             treatment or follow-up schedule unlikely

          -  Known or suspected hypersensitivity to any of the constituents of either
             investigational product (CTAP101) or adjunctive vitamin D hormone therapy