Clinical trial NCT05232370: The Effect of Enalapril, Losartan or Not Antihypertensive on the Oxidative Status in Renal Transplant Recipients
Official title: The Effect of Enalapril, Losartan or Not Antihypertensive on the Oxidative Status in Renal Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Oxidative Stress
Lead sponsor: Unidad de Investigacion Medica en Enfermedades Renales
Sponsor class: OTHER
First posted: 2022-02-09
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three groups are made

1. - Control group: No treatment
2. - Tratment group: Enalapril
3. - Treatment group: Losartan
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Products of lipoperoxidation (LPO) (oxidative stress molecule)
timeFrame: 1 year after renal transplant
measure: Nitric Oxide (NO) (oxidative stress molecule)
timeFrame: 1 year after renal transplant
Secondary outcomes:
measure: Superoxide dismutase (SOD) (Antioxidative molecule)
timeFrame: 1 year after renal transplant
measure: Glutathione peroxidase (GPx) (Antioxidative molecule)
timeFrame: 1 year after renal transplant
measure: Total Antioxidant Capacity (TAC) (Antioxidative molecule)
timeFrame: 1 year after renal transplant
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Enrique Rojas Campos
state: Jalisco
Study officials:
References: