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临床试验/NCT01271478
NCT01271478已完成4 期

Effect of Telmisartan and Captopril on Systemic Inflammation of Patients on Hemodialysis

Coordinación de Investigación en Salud, Mexico1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2009年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Serum concentrations of TNF-a, IL-6 and CRP

研究概览

简要总结

The aim of this study was to compare the dual use of telmisartan and captopril vs the individual use of such drugs and placebo on the systemic inflammation of patients on hemodialysis (HD).

详细描述

Once included, patients will be randomly allocated (by a computer-generated randomization list) to one of the following groups: group 1 will receive Captopril, group 2 Telmisartan, group 3 Captopril plus Telmisartan, and group 4 Placebo. Drugs will be provided as tablets during a period of 3 months. All patients will have 3 HD sessions per week, with the same kind of single-use dialysis membrane and dialysate Monthly visits will be scheduled for clinical and biochemical evaluations. A blood sample will be taken at baseline and every month for measurement of complete blood count, urea, creatinine, glucose, albumin, lipids, and electrolytes (measured by usual methods). In serum samples at 0, 1 and 3 months, tumor necrosis factor alpha (TNF-α) and interleukin 6 (IL-6) concentrations will be measured by ELISA using high sensitivity kits. Additionally, in the same serum samples, C-reactive protein (CRP) concentrations will be measured by nephelometry using high sensitivity kits. All laboratory measurements, including inflammation markers, will be performed in the Central Laboratory (Hospital de Especialidades, Centro Médico Nacional de Occidente), by the same personnel blinded to patient's details.

Treatment compliance will be recorded by counting tablets left in the container at the end of each monthly visit.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥18 years
  • ≥2 months on hemodialysis
  • Arteriovenous fistula as vascular access
  • Endorsement of informed consent

排除标准

  • Inflammatory cause of ESRD
  • Liver disease, cancer, AIDS
  • Any infectious disease 2 months before the study
  • Failed kidney graft
  • Hypersensitivity to angiotensin converting enzyme inhibitors or angiotensin receptor blockers
  • Arterial hypotension
  • Pregnancy
  • Treatment with antibiotics, non-steroidal anti-inflammatory drugs, steroids, immunosuppressives, statins, ACE inhibitors or ARB 3 months previous to the study

研究组 & 干预措施

Placebo

Placebo Comparator

2 tablets of placebo orally twice a day

干预措施: Placebo (Drug)

Telmisartan plus Captopril

Experimental

captopril 50 mg/day (1 tablet of 25 mg orally twice a day) plus telmisartan 80 mg/day (1 tablet of 40 mg orally twice a day)

干预措施: Telmisartan plus Captopril (Drug)

Telmisartan plus Placebo

Experimental

telmisartan 80 mg/day (1 tablet of 40 mg orally twice a day) plus 1 tablet of placebo orally twice a day

干预措施: telmisartan plus placebo (Drug)

Captopril plus Placebo

Experimental

patients received captopril 50 mg/day (1 tablet of 25 mg orally twice a day) plus 1 tablet of placebo orally twice a day

干预措施: captopril plus placebo (Drug)

结局指标

主要结局

Serum concentrations of TNF-a, IL-6 and CRP

时间窗: 3 months

次要结局

未报告次要终点

研究者

发起方
Coordinación de Investigación en Salud, Mexico
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Alfonso Martín Cueto Manzano

Head, Medical Research Unit of Renal Diseases

Coordinación de Investigación en Salud, Mexico

研究点 (1)

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