NCT00257920已完成4 期
A Phase 4, Single-Center, Open-Label, Randomized, Active-Controlled, Cross-over Pilot Study to Evaluate the Effects of Two Vitamin D Analogs, Zemplar® Injection and Hectorol® Injection, on Intestinal Absorption of Calcium in CKD Stage 5 Subjects on Hemodialysis
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 41
- 主要终点
- Calcium Absorption Fractions Analyzed by Analysis of Variance (ANOVA)
研究概览
简要总结
The purpose of this study is to evaluate the effects of Zemplar® Injection and Hectorol® Injection on intestinal calcium absorption in Chronic Kidney Disease Stage 5 subjects on hemodialysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is >= 20 years of age.
- •Subject is diagnosed with CKD Stage 5, and must be on maintenance (chronic) hemodialysis (HD) three times a week for at least 2 months prior to the Screening Visit and expected to remain on HD for the duration of the study.
- •If female, subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or is of childbearing potential and practicing one of the following methods of birth control:
- •Condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD)
- •Contraceptives (oral or parenteral) for three months prior to study drug administration
- •In a monogamous relationship with a vasectomized partner
- •If female, subject is not breastfeeding and has a negative serum pregnancy test prior to the treatment phase.
- •Subject has an intact PTH value > 200 pg/mL at Screening only (or Re-screening, if applicable).
- •Subject has a serum calcium level < 10.2 mg/dL at Screening only (or Re-screening, if applicable).
- •Subject has a serum phosphorus level < 6.5 mg/dL at Screening only (or Re-screening, if applicable).
- •Subject has a CaxP product <= 65 at Screening only (or Re-screening, if applicable).
- •Subject must voluntarily sign and date an informed consent, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), prior to the conduct of any study-specific procedure.
排除标准
- •Subject has a history of an allergic reaction or significant sensitivity to vitamin D or vitamin D related compounds.
- •Subject has chronic gastrointestinal disease, which in the Investigator's opinion, may result in clinically significant GI malabsorption.
- •Liver function defects defined as > 2 times the upper limit of normal for liver enzyme (SGOT/AST, SGPT/ALT) levels.
- •Subject has a hemoglobin level < 9.0 g/dL.
- •Subject is taking maintenance calcitonin, Sensipar® (cinacalcet), glucocorticoids in an equivalent dose > 5 mg prednisone daily, or other drugs that may affect calcium or bone metabolism within 2 weeks prior to screening, other than females on stable (same dose and product for 3 months) estrogen and/or progestin therapy.
- •For any reason, subject is considered by the Investigator to be an unsuitable candidate to receive pharmacological doses of vitamin D.
- •Subject has received any investigational drug within 4 weeks prior to the Treatment Phase.
研究组 & 干预措施
A
Active Comparator
干预措施: Zemplar® injection (Drug)
B
Active Comparator
干预措施: Hectorol® injection (Drug)
结局指标
主要结局
Calcium Absorption Fractions Analyzed by Analysis of Variance (ANOVA)
时间窗: 42 Days
Calcium Absorption Fraction obtained at the end of Period 1 \& Period 2
次要结局
- Calcium Absorption Fractions Analyzed by Mixed Model(42 Days)
研究者
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