EUCTR2004-002174-32-GB进行中（未招募）1 期
An open label, randomized, parallel design study to investigate the efficacy and safety of sevelamer hydrochloride (Renagel®) compared with calcium acetate in peritoneal dialysis patients (REN00304)
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 250
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Willing and able to sign an informed consent form.
- •2. Men or women aged 18 years of age or older.
- •3. Decrease the requirement for patients to have been stable on PD to 8 weeks.
- •4. In the opinion of the investigator, expected to receive peritoneal dialysis for the duration of the study.
- •5. Reduce the baseline inclusion criteria for serum phosphorus to > 1.76 mmol/L (5.50 mg/dL).
- •6. Increase the inclusion criteria for the upper limit of serum calcium (adjusted for albumin) levels as measured at the baseline visit to 2.60 mmol/L (10.40 mg/dL).
- •7. Willing to maintain the prescribed sevelamer or calcium acetate for the duration of the study.
- •8. Considered compliant with phosphate binders and dialysis.
- •9. Remove the criteria for inclusion of iPTH altogether.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patients with a history of peritonitis in the last 30 days or > 2 episodes in the last 12 months
- •2. Patient with active dysphagia, swallowing disorder, bowel obstruction, or severe gastrointestinal motility disorder.
- •3. Patients who in the opinion of the investigator have poorly controlled diabetes mellitus, poorly controlled hypertension, active vasculitis, HIV infection, or any clinically significant, unstable medical condition.
- •4. Patients with any evidence of active malignancy except for basal cell carcinoma of the skin. A history of malignancy is not exclusion.
研究者
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