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

NCT ID: NCT05232370

Last Updated: 2022-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2022-01-06

Brief 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.

Conditions

Oxidative Stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control Group

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)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Enalapril group

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

Group Type: EXPERIMENTAL

Angiotensin converting enzyme inhibitor

Intervention Type: DRUG

Angiotensin-converting enzyme inhibitors after Kidney Transplant

Losartan group

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

Group Type: EXPERIMENTAL

Angiotensin Receptor Blockers

Intervention Type: DRUG

Angiotensin receptor blockers after Kidney Transplant

Interventions

Angiotensin converting enzyme inhibitor

Angiotensin-converting enzyme inhibitors after Kidney Transplant

Intervention Type: DRUG

Angiotensin Receptor Blockers

Angiotensin receptor blockers after Kidney Transplant

Intervention Type: DRUG

Other Intervention Names

Enalapril; Losartan

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Unidad de Investigacion Medica en Enfermedades Renales

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Enrique Rojas Campos

Guadalajara, Jalisco, Mexico

Countries

Mexico

Other Identifiers

UIMER004

Identifier Type: -

Identifier Source: org_study_id