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

Unidad de Investigacion Medica en Enfermedades Renales

Status and phase

Completed

Phase 2

Conditions

Oxidative Stress

Treatments

Drug: Angiotensin Receptor Blockers

Drug: Angiotensin converting enzyme inhibitor

Study type

Interventional

Funder types

Other

Identifiers

NCT05232370

UIMER004

Details and patient eligibility

About

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.

Full 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.

Enrollment

39 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

39 participants in 3 patient groups

Control Group

No Intervention group

Description:

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)

Enalapril group

Experimental group

Description:

Treatment:

Drug: Angiotensin converting enzyme inhibitor

Losartan group

Experimental group

Description:

Treatment:

Drug: Angiotensin Receptor Blockers