Multi-centre, Open-label, Randomized Trial to Determine the Effect of Icodextrin (Extraneal) Versus Dextrose (Dianeal 2.5%) Used in Long-dwell Exchange, Measuring the HOMA Index in Non-diabetic Prevalent CAPD Patients
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- HOMA index
研究概览
简要总结
Phase IV post-marketing study to evaluate the effect of Extraneal on the HOMA index in non-diabetic CAPD patients over the long-dwell exchange. The purpose of the study is to investigate if the use of Extraneal (which is a mixture of high weight glucose polymers), instead of glucose-based solutions such as Dianeal is going to lower the HOMA index in non-diabetic CAPD patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •must be over 18-years old and under 75-years old
- •Peritoneal Equilibration Test (PET) result of high, high average or low average transport
- •non-diabetic patient
- •be in Continuous Ambulatory Peritoneal Dialysis (CAPD)
- •prevalent patients that have been in peritoneal dialysis at least 30 days
- •wish to participate
排除标准
- •Have a Charlson score of >7 and have a life expectancy of less than 12 months
- •HIV positive
- •present with peritonitis in the month prior to randomisation
- •present with cardiovascular, metabolic or infection complications that have required hospitalisation in the month prior to the randomisation
- •have active cancer
- •pregnant women
- •patients with known allergy to starch-based polymer
- •patients who have a significant psychiatric disorder or mental disability that could interfere with the patient´s ability to provide Informed Consent and comply with the protocol procedures
- •women incapable of maintaining an effective and accepted contraception method
研究组 & 干预措施
Dianeal only
Patients in Dianeal during the daily exchanges and randomised to Dianeal during the long-dwell exchange
干预措施: Blood samples (Procedure)
Dianeal only
Patients in Dianeal during the daily exchanges and randomised to Dianeal during the long-dwell exchange
干预措施: Measure of peritoneal ultrafiltrates (Procedure)
Dianeal; Extraneal long-dwell exchange
Patients in Dianeal during the daily exchanges and randomised to Extraneal during the long-dwell exchange
干预措施: Blood samples (Procedure)
Dianeal; Extraneal long-dwell exchange
Patients in Dianeal during the daily exchanges and randomised to Extraneal during the long-dwell exchange
干预措施: Measure of peritoneal ultrafiltrates (Procedure)
结局指标
主要结局
HOMA index
时间窗: 4 months
Measure the changes in the levels of the HOMA index when Extraneal (7.5%) is being administered in the long-dwell exchange and compare these levels to the HOMA index resulting when using Dianeal 2.5% in the long-dwell exchange in non-diabetic CAPD patients. This outcome will be evaluated by measurements taken monthly over a period of 4 months.
次要结局
- HbA1c(12 months)
- Ultrafiltration of long-dwell exchange(12 months)
- Blood pressure(12 months)
- Quality of life(12 months)
- Hospitalization rate(12 months)
- Time during hospitalization(12 months)
- Incidence of Adverse Events(12 months)