A Randomized, Double Blind, Placebo-Controlled, Repeat Dose, Safety, Efficacy and Pharmacokinetic/Pharmacodynamic Study of CTAP101 Capsules in Subjects With Chronic Kidney Disease, Vitamin D Insufficiency and Secondary Hyperparathyroidism
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Proportion (%) of Subjects With Serum 25-hydroxyvitamin D ≥30 ng/mL (PP).
研究概览
简要总结
This study will investigate how the levels of a repeat dose of CTAP101 changes in the body over time (pharmacokinetics, PK) and how CTAP101 affects other mineral and hormonal balances (pharmacodynamics, PD) in patients with chronic kidney disease (CKD, vitamin D insufficiency and secondary hyperparathyroidism (SHPT).
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Urinary albumin excretion of ≤3000 μg of creatinine
- •Stage 3 CKD
- •Plasma iPTH: > 70 pg/mL and < 500 pg/mL
- •Serum Ca: ≥ 8.4 mg/dL and < 10.0 mg/dL
- •Serum P: ≥ 2.0 mg/dL and < 5.0 mg/dL
- •Serum 25-hydroxyvitamin D: > 10 ng/mL and < 29 ng/mL.
- •Discontinue vitamin D use for duration of study
排除标准
- •History of kidney transplant or parathyroidectomy
- •Spot urine calcium:creatinine ratio > 0.2
- •Current serious illness, such as malignancy, HIV, liver disease, cardiovascular event or hepatitis
- •Currently on dialysis
研究组 & 干预措施
Cohort 1: CTAP101 Capsules 60µg
干预措施: Cohort 1 CTAP101 Capsules- 60µg (Drug)
Cohort 1: CTAP101 Capsules 90µg
干预措施: Cohort 1 CTAP101 Capsules - 90µg (Drug)
Cohort 1: Sugar Capsule
干预措施: Cohort 1 Matching Sugar Capsule (Drug)
Cohort 2: CTAP101 Capsules 30µg
干预措施: Cohort 2 CTAP101 Capsules - 30µg (Drug)
Cohort 2: Sugar Capsule
干预措施: Cohort 2 Matching Sugar Capsule (Drug)
结局指标
主要结局
Proportion (%) of Subjects With Serum 25-hydroxyvitamin D ≥30 ng/mL (PP).
时间窗: 6 weeks
The proportion of subjects in the per protocol population with serum 25-hydroxyvitamin D ≥30 ng/mL at End-of-Treatment (EOT; Week 6) in Cohorts 1 and 2 (60/90 and 30 μg groups, respectively) were compared to their corresponding placebo groups.
Mean Percent Change From Baseline in Plasma Intact Parathyroid Hormone (iPTH) to End of Treatment (Per Protocol Population)
时间窗: 6 weeks
Mean percent change from baseline in plasma intact parathyroid hormone (iPTH) from baseline to End of Treatment (EOT) in the Per Protocol population. Subjects in Cohorts 1 and 2 (dose regimens 60/90 and 30 mcg, respectively) were compared to their respective placebo groups.
次要结局
- Change From Baseline in Serum 25-hydroxyvitamin D at Week 6(Baseline to End of Treatment (6 weeks))
- Percent Change From Baseline in Serum 25-hydroxyvitamin D at End of Treatment (EOT, Week 6) in the Per Protocol Population(Baseline to End of Treatment (6 weeks))
- Proportion of Subjects With Reduction of Intact Parathyroid Hormone (iPTH) of at Least 30% at Week 6(Baseline to End of Treatment (6 weeks))
- Proportion of Subjects With Reduction of Intact Parathyroid Hormone (iPTH) of at Least 20% at Week 6(Baseline to End of Treatment (6 weeks))