NCT00073710已完成4 期
A Phase IV, Single-Center, Active-Controlled Cross-Over Pilot Study to Evaluate the Effects of Zemplar Injection and Calcijex on Intestinal Absorption of Calcium
Abbott1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2004年9月1日最近更新:
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试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The mean within subject difference in calcium absorption rates between treatment regimens will be analyzed using ANOVA appropriate for a two-period cross-over trial.
研究概览
简要总结
A study to investigate the effects of Zemplar and Calcijex on intestinal calcium absorption in hemodialysis subjects.
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
- Double
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 ESRD, and must be on maintenance hemodialysis (HD) three times a week for at least 2 months prior to the Screening Phase 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 had an intact PTH value > 200 pg/mL.
- •Serum calcium level < 10.2 mg/dL at Screening visit.
- •Serum phosphorus level < 6.5 mg/dL at Screening visit.
- •Ca´P product ≤ 65 at Screening visit.
- •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 or > 1.5 times the upper limit of normal coagulation levels.
- •Subject is taking maintenance calcitonin, glucocorticoids in an equivalent dose > 5 mg prednisone, or other drugs that may affect calcium or bone metabolism, 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.
结局指标
主要结局
The mean within subject difference in calcium absorption rates between treatment regimens will be analyzed using ANOVA appropriate for a two-period cross-over trial.
次要结局
未报告次要终点
研究者
研究点 (1)
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