EUCTR2017-001899-32-ES进行中（未招募）1 期
Crossover and randomized clinical trial on the effect of Resincolestiramine in the intestinal absorption of new uremic toxins in patients in hemodialysis with chronic renal insufficiency - RESINFENO
Dr. Abelardo Aguilera Peralta0 个研究点目标入组 58 人开始时间: 2017年8月2日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 58
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
入选标准
- •Patients who give their written consent to participate in the study.
- •Men and women between 18 and 80 years
- •Women of childbearing potential should use an effective contraceptive method (hormonal contraceptives, intrauterine device, condom) or refrain from having sex in order not to get pregnant. A woman is considered to be fertile after menarche and to become postmenopausal, unless she has undergone a permanent sterilization procedure (hysterectomy, salpingectomy, bilateral oophorectomy). A postmenopausal state is defined as absence of menstruation for 12 months without an alternative medical cause
- •Adequate dialysis criteria according to the KDOQI guidelines: Target of spKt / V> 1.4 per hemodialysis session for patients treated three times per week
- •Stable renal disease in the last 3 months. Chronic kidney disease is considered stable when it meets the following criteria:
- •-The associated chronic pathologies are adequately controlled and have not required hospitalization in the last 3 months.
- •-The patient has no hemodynamic changes (AT = 90/60 and = 160/90 mm Hg) outside the hemodialysis session.
- •-There are no signs of acute infection valued by the absence of leukocytosis in the blood count
- •-There is no clinical evidence of tumor pathology at the discretion of the investigator
- •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 38
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •Pregnant or lactating women.
- •Total cholesterol values lower than 150 mg/dL with or without lipid-lowering treatment.
- •Hemoglobin value =10 mg / dL (according to KDOQI guidelines).
- •Serum PTH levels =750 pg / mL (moderate hyperparathyroidism).
- •Prothrombin activity below 80% and / or treatment with acenocoumarol or warfarin
- •Patients receiving Resincolestiramine on medical advice.
- •Antecedents of autoimmune diseases and / or treatment with immunosuppressants
- •Hypersensitivity to the active substance or to any of the excipients (carboxymethylcellulose, propylene glycol alginate, colloidal silica, sodium saccharin, sodium cyclamate, strawberry flavor)
- •History of peptic ulcer
- •Complete biliary obstruction
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