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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Oxidative Stress

Intervention / Treatment
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* Drug: Angiotensin converting enzyme inhibitor
* Drug: Angiotensin Receptor Blockers


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Three groups are made - Control group: No treatment - Tratment group: Enalapril - Treatment group: Losartan
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>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 control group (Without losartan or enalapril) | |
| Experimental: Enalapril group<br>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 | Drug: Angiotensin converting enzyme inhibitor<br>* Angiotensin-converting enzyme inhibitors after Kidney Transplant<br>* Other names: Enalapril;|
| Experimental: Losartan group<br>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 | Drug: Angiotensin Receptor Blockers<br>* Angiotensin receptor blockers after Kidney Transplant<br>* Other names: Losartan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Products of lipoperoxidation (LPO) (oxidative stress molecule) | Measured in mM | 1 year after renal transplant | 
| Nitric Oxide (NO) (oxidative stress molecule) | Measured in µg/mL | 1 year after renal transplant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Superoxide dismutase (SOD) (Antioxidative molecule) | Measured in U/L | 1 year after renal transplant | 
| Glutathione peroxidase (GPx) (Antioxidative molecule) | Measured in nmol/min/mL | 1 year after renal transplant | 
| Total Antioxidant Capacity (TAC) (Antioxidative molecule) | Measured in µM | 1 year after renal transplant |