The Effect of Enalapril, Losartan or Not Antihypertensive on the Oxidative Status in Renal Transplant Recipients
Condition: Oxidative Stress
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Angiotensin converting enzyme inhibitor; Angiotensin Receptor Blockers
Intervention type(s): Drug; Drug
Intervention description(s): Angiotensin-converting enzyme inhibitors after Kidney Transplant; Angiotensin receptor blockers after Kidney Transplant
Other intervention name(s): Enalapril; Losartan
Intervention MeSH terms: Losartan; Enalapril; Angiotensin Receptor Antagonists; Angiotensin-Converting Enzyme Inhibitors; Enzyme Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Three groups are made
- Control group: No treatment
- Tratment group: Enalapril
- Treatment group: Losartan
Masking: None (Open Label)
Primary purpose: Treatment