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临床试验/NCT05232370
NCT05232370已完成2 期

The Effect of Enalapril, Losartan or Not Antihypertensive on the Oxidative Status in Renal Transplant Recipients

Unidad de Investigacion Medica en Enfermedades Renales1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2022年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
39
试验地点
1
主要终点
Products of lipoperoxidation (LPO) (oxidative stress molecule)

研究概览

简要总结

The clinical and biochemical improvement observed in kidney transplant (RT) recipients is remarkable. The correct functioning of the allograft depends on various factors such as the donor's age, the alloimmune response, the ischemia-reperfusion injury, arterial hypertension, and the interstitial fibrosis of the allograft, among others. Antihypertensive drugs are necessary for arterial hypertension patients to avoid or reduce the probability of affecting graft function in RT recipients. Oxidative stress (OS) is another complex pathophysiological process with the ability to alter post-transplant kidney function. The study's objective was to determine the effect of the administration of Enalapril, Losartan, or not antihypertensive medication on the oxidative state in RT recipients at the beginning of the study and one year of follow-up.

详细描述

An open, randomized clinical trial is proposed with a control group. It is carried out in the Transplant Division of the High Specialty Medical Unit of the Hospital de Especialidades, Centro Médico Nacional de Occidente of the Mexican Institute of Social Security in Guadalajara, Jalisco, Mexico. The sample size was based on the formula to evaluate mean differences for clinical trials. Three study groups were formed; thirteen patients with RT who did not require any antihypertensive. Thirteen RT patients to receive Enalapril as an antihypertensive regimen. Thirteen RT patients to receive Losartan as an antihypertensive regimen in the post-transplant period. Recipients of a RT, from a living related donor (DVR) or living unrelated donor (DVNoR) who agreed to participate and signed the Letter of Consent under Information.

Patients who received an RT from a deceased donor, from a donor >55 years, with renal comorbidities at the time of the study (urolithiasis, infections, diabetes), with blood dyscrasias, second transplantation, treatment with non-steroidal anti-inflammatory drugs, statins, spironolactone, pentoxifylline, patients with neurodegenerative processes or who withdrew the Letter of Consent under Information are not eligeble.

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
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Renal trasplant, from a living related donor (DVR) or living unrelated donor (DVNoR)
  • Who agreed to participate and signed the Letter of Consent under Information.

排除标准

  • Patients who received an RT from a deceased donor,
  • With donor >55 years,
  • With renal comorbidities at the time of the study (urolithiasis, infections, diabetes),
  • With blood dyscrasias,
  • Second transplantation,
  • Those with treatment with non-steroidal anti-inflammatory drugs,
  • Treatment with statins, spironolactone, pentoxifylline, patients
  • With neurodegenerative processes
  • Those who withdrew the Letter of Consent under Information

研究组 & 干预措施

Enalapril group

Experimental

Recipients of a RT, from a living related donor (DVR) or living unrelated donor (DVNoR) who agreed to participate and signed the Letter of Consent under Information.

Randomly assigned to Enalapril group

干预措施: Angiotensin converting enzyme inhibitor (Drug)

Losartan group

Experimental

Recipients of a RT, from a living related donor (DVR) or living unrelated donor (DVNoR) who agreed to participate and signed the Letter of Consent under Information.

Randomly assigned to Losartan group

干预措施: Angiotensin Receptor Blockers (Drug)

结局指标

主要结局

Products of lipoperoxidation (LPO) (oxidative stress molecule)

时间窗: 1 year after renal transplant

Measured in mM

Nitric Oxide (NO) (oxidative stress molecule)

时间窗: 1 year after renal transplant

Measured in µg/mL

次要结局

  • Glutathione peroxidase (GPx) (Antioxidative molecule)(1 year after renal transplant)
  • Total Antioxidant Capacity (TAC) (Antioxidative molecule)(1 year after renal transplant)
  • Superoxide dismutase (SOD) (Antioxidative molecule)(1 year after renal transplant)

研究者

发起方
Unidad de Investigacion Medica en Enfermedades Renales
申办方类型
Other
责任方
Sponsor

研究点 (1)

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