A Long-term Safety and Efficacy Study of CTAP101 Capsules in Subjects With Stages 3 or 4 Chronic Kidney Disease, Secondary Hyperparathyroidism and Vitamin D Insufficiency (Extension of Study CTAP101-CL-3001 or CTAP101-CL-3002)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 298
- 主要终点
- Number of Participants in the Intent to Treat Population With a Mean Reduction in Plasma Intact Parathyroid Hormone (iPTH) of >/= 30% From Baseline Values at End of Treatment (EOT)
研究概览
简要总结
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.
详细描述
Only subjects previously enrolled in studies CTAP101-CL-3001 or CTAP101-CL-3002 are eligible to participate in this extension study. This is a phase 3, open-label study of CTAP101 Capsules, with and without add-on vitamin D hormone therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
CTAP101 Capsules +calcitriol
CTAP101 Capsules 60 mcg +calcitriol daily for 14 weeks
干预措施: CTAP101 Capsules (Drug)
CTAP101 Capsules +calcitriol
CTAP101 Capsules 60 mcg +calcitriol daily for 14 weeks
干预措施: Calcitriol (Drug)
CTAP101 Capsules alone
CTAP101 Capsules 30 or 60 mcg daily for up to 26 weeks
干预措施: CTAP101 Capsules (Drug)
CTAP101 Capsules +doxercalciferol
CTAP101 Capsules 60 mcg +doxercalciferol daily for 14 weeks
干预措施: CTAP101 Capsules (Drug)
CTAP101 Capsules +doxercalciferol
CTAP101 Capsules 60 mcg +doxercalciferol daily for 14 weeks
干预措施: Doxercalciferol (Drug)
CTAP101 Capsules +paricalcitol
CTAP101 Capsules 60 mcg +paricalcitol daily for 14 weeks
干预措施: CTAP101 Capsules (Drug)
CTAP101 Capsules +paricalcitol
CTAP101 Capsules 60 mcg +paricalcitol daily for 14 weeks
干预措施: Paricalcitol (Drug)
结局指标
主要结局
Number of Participants in the Intent to Treat Population With a Mean Reduction in Plasma Intact Parathyroid Hormone (iPTH) of >/= 30% From Baseline Values at End of Treatment (EOT)
时间窗: up to 6 months
Number of subjects in the intent to treat population with a mean reduction in plasma intact parathyroid hormone (iPTH) of \>/= 30% from pretreatment baseline values at end of treatment (EOT), classified as responders
次要结局
- Number of Participants in the Per Protocol Population With Mean Reduction in Plasma Intact Parathyroid Hormone (iPTH) of >/= 30% From Baseline Values at End of Treatment (EOT)(up to 6 months)
- Number of Participants in the Intent to Treat Population With Normal Serum 25-hydroxyvitamin D at End of Treatment (EOT)(up to 6 months)
- Number of Participants in the Per Protocol Population With NormalSerum 25-hydroxyvitamin D at End of Treatment (EOT)(up to 6 months)