NCT01130831已完成不适用
A Phase IV, Multi-Centre, Non-interventional Study Evaluating the Effect of Lanthanum Carbonate in Patients Previously Treated With Calcium Based Phosphate Binder Therapy on Serum Phosphorous Control, Concomitant Vitamin D Therapy and Bone Related Biochemical Parameters in End Stage Renal Disease Patients on Hemodialysis
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相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Shire
- 入组人数
- 66
- 试验地点
- 30
- 主要终点
- Percent of Subjects That Achieved Controlled Serum Phosphorous Levels on Lanthanum Carbonate
研究概览
简要总结
To assess the percentage of patients on lanthanum carbonate, that achieve Kidney Disease Outcome Quality Initiative (KDOQI) guideline suggested values for serum phosphorous in patients previously treated with calcium-based phosphate binder therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Patients meeting all of the criteria listed below may be included in the study:
- •Patients aged over 18 years
- •Patients with ESRD on haemodialysis who are willing and able to provide written informed consent.
- •Patients on:
- •Lanthanum carbonate monotherapy for ≥1 month
- •Lanthanum carbonate monotherapy for ≤3 months
- •Calcium-based monotherapy for ≥3 months immediately prior to lanthanum carbonate therapy.
- •Values recorded in medical records detailing serum phosphorous, serum calcium-phosphorus product, iPTH, and medication ≤6 months prior to commencing lanthanum carbonate therapy and whilst on a calcium-based monotherapy.
排除标准
- •Patients are excluded from the study if any of the following criteria are met at screening:
- •Known or suspected intolerance or hypersensitivity to lanthanum, or any of the stated ingredients
- •Patients with known hypophosphatemia (phosphate level below lower level of normal)
- •Patients with severe hepatic impairment
- •Patients with requirement for calcium supplementation for reasons other than CKD
- •Pregnant or lactating women and women planning to become pregnant over the next 12 months
结局指标
主要结局
Percent of Subjects That Achieved Controlled Serum Phosphorous Levels on Lanthanum Carbonate
时间窗: 12 months
Phosphorous levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum phosphorous of 3.5-5.5 mg/dL.
Percent of Subjects That Achieved Controlled Serum Phosphorous Levels on Calcium-based Phosphate Binder Therapy
时间窗: Baseline
Phosphorous levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum phosphorous of 3.5-5.5 mg/dL.
次要结局
- Percent of Subjects That Achieved Controlled Serum Calcium Levels on Calcium-based Phosphate Binder Therapy(Baseline)
- Percent Change From Baseline in Phosphorous Levels at 12 Months(Baseline and 12 months)
- Percent Change From Baseline in iPTH Levels at 12 Months(Baseline and 12 months)
- Percent of Subjects With Hypercalcemic Events on Lanthanum Carbonate(12 months)
- Percent of Subjects That Achieved Controlled Serum Calcium Levels on Lanthanum Carbonate Therapy(12 months)
- Percent of Subjects That Maintained Control of Serum Calcium-Phosphorous Product Levels on Lanthanum Carbonate Therapy(12 months)
- Percent of Subjects That Achieved Controlled Serum Calcium-Phosphorous Product Levels on Calcium-based Phosphate Binder Therapy(Baseline)
- Percent of Subjects That Maintained Control of Serum Phosphorous Levels on Lanthanum Carbonate(12 months)
- Percent of Subjects That Maintained Control of Serum Calcium Levels on Lanthanum Carbonate(12 months)
- Percent of Subjects That Achieved Controlled Serum Calcium-Phosphorous Product Levels on Lanthanum Carbonate Therapy(12 months)
- Percent of Subjects That Maintained Control of Intact Parathyroid Hormone (iPTH) Levels on Lanthanum Carbonate Therapy(12 months)
- Percent Change From Baseline in 25-Hydroxy Vitamin D Levels at 12 Months(Baseline and 12 months)
- Percent of Subjects With Hypocalcemic Events on Calcium-based Phosphate Binder Therapy(Baseline)
- Percent of Subjects With Hypocalcemic Events on Lanthanum Carbonate(12 months)
- Change From Baseline in Vitamin D Dose at 12 Months(Baseline and 12 months)
- Change From Baseline in Mean Total Daily Dose of Calcium at 12 Months(Baseline and 12 months)
- Percent Change From Baseline in Calcium Levels at 12 Months(Baseline and 12 months)
- Percent Change From Baseline in Calcium-Phosphorous Product Levels at 12 Months(Baseline and 12 months)
- Percent Change From Baseline in 1,25-Hydroxy Vitamin D Levels at 12 Months(Baseline and 12 months)
- Percent of Subjects With Hypercalcemic Events on Calcium-based Phosphate Binder Therapy(Baseline)
- Number of Tablets Per Day(12 months)
研究者
研究点 (30)
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