NCT00681941已完成3 期
An Open Label, Dose Titration of Sevelamer Carbonate Tablets Dosed Three Times a Day in Hyperphosphatemic Chronic Kidney Disease Patients Not On Dialysis
Genzyme, a Sanofi Company25 个研究点 分布在 5 个国家目标入组 49 人开始时间: 2006年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 25
- 主要终点
- Evaluate the efficacy of sevelamer carbonate tablets dosed three times per day (TID) with meals on control of serum phosphorus levels
研究概览
简要总结
Approximately 45 hyperphosphatemic CKD patients not on dialysis will be entered into this study at approximately 20 sites within Europe and 5-10 in Australia. The purpose of this study is to determine if sevelamer carbonate tablets dosed three times a day (TID) is an effective treatment for the control of serum phosphorous levels in hyperphosphatemic CKD patients not on dialysis. Total length of participation is approximately 14 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •A minimum of 120 male and female patients with chronic kidney disease not requiring dialysis will be screened for participation in the study.
- •Men or woman 18 years of age or older
- •If currently taking phosphate binder(s), willing to stop this and enter a 2 week washout period
- •Willing to avoid any intentional changes in diet such as fasting or dieting
- •Have the following central laboratory measurements:
- •If not on a phosphate binder, a serum phosphorus measurement ≥ 5.5 mg/dL (1.76 mmol/L) at Screening (Visit1).
- •If taking a phosphate binder(s) at screening, a serum phosphorus measurement ≥ 5.5 mg/dL (1.76 mmol/L) after the two-week washout period at Visit 1a (Day 0).
- •At Screening (Visit 1), have the following central laboratory measurements:
- •25-hydroxyvitamin D ≥ 10 ng/mL
- •iPTH ≤ 800 pg/mL
- •Willing and able to take sevelamer carbonate alone as a phosphate binder for the duration of the study
- •Willing and able to maintain screening doses of lipid medication, 1,25 dihydroxyvitamin D, and/or cinacalcet for the duration of the study, except for safety reasons
- •Willing and able to avoid antacids and phosphate binders containing aluminum, magnesium, calcium or lanthanum for the duration of the study unless prescribed as an evening calcium supplement
- •If female and of childbearing potential (pre-menopausal and not surgically sterile), willing to use an effective contraceptive method throughout study, which includes barrier methods, hormones, or IUDs
- •Expecting not to initiate dialysis for the duration of this study
- •Considered compliant with phosphate binders (if applicable)
- •Willing and able to provide informed consent
- •Has not participated in any other investigational drug studies within 30 days prior to enrollment,
- •Level of understanding and willingness to cooperate with all visits and procedures as described by the study personnel
排除标准
- •Active bowel obstruction, dysphagia, swallowing disorder or severe gastrointestinal (GI) motility disorders
- •Active ethanol or drug abuse, excluding tobacco use
- •Use of anti-arrhythmic or anti-seizure medications for arrhythmia or seizure disorders.
- •In the opinion of the investigator, patient has poorly controlled diabetes mellitus, poorly controlled hypertension, active vasculitis, HIV infection, or any clinically significant unstable medical condition
- •Pregnant or breast-feeding
- •Evidence of active malignancy except for basal cell carcinoma of the skin
- •Unable to comply with the requirements of the study
- •Known hypersensitivity to sevelamer or any constituents of the study drug
- •Any other condition, which in the opinion of the investigator will prohibit the patient's inclusion in the study
研究组 & 干预措施
1
Experimental
Sevelamer Carbonate Tablets Dosed Three Times A Day
干预措施: Sevelamer carbonate (Renvela®) (Drug)
结局指标
主要结局
Evaluate the efficacy of sevelamer carbonate tablets dosed three times per day (TID) with meals on control of serum phosphorus levels
时间窗: Up to day 70
Evaluate the safety and tolerability of sevelamer carbonate tablets dosed TID with meals.
时间窗: Up to day 70
次要结局
- Serum calcium-phosphorus product(Up to day 70)
- Serum lipid profile [total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol](Up to day 70)
- Percent responders [serum phosphorus between 2.7 and 4.6 mg/dL (0.87 and 1.49 mmol/L) inclusive] at Day 56/ET(Up to day 70)
研究者
研究点 (25)
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