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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05232370
Enrollment
39
Registered
2022-02-09
Start date
2022-01-01
Completion date
2022-01-06
Last updated
2022-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oxidative Stress

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.

Interventions

Angiotensin-converting enzyme inhibitors after Kidney Transplant

Angiotensin receptor blockers after Kidney Transplant

Sponsors

Unidad de Investigacion Medica en Enfermedades Renales
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Three groups are made 1. \- Control group: No treatment 2. \- Tratment group: Enalapril 3. \- Treatment group: Losartan

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Products of lipoperoxidation (LPO) (oxidative stress molecule)1 year after renal transplantMeasured in mM
Nitric Oxide (NO) (oxidative stress molecule)1 year after renal transplantMeasured in µg/mL

Secondary

MeasureTime frameDescription
Superoxide dismutase (SOD) (Antioxidative molecule)1 year after renal transplantMeasured in U/L
Glutathione peroxidase (GPx) (Antioxidative molecule)1 year after renal transplantMeasured in nmol/min/mL
Total Antioxidant Capacity (TAC) (Antioxidative molecule)1 year after renal transplantMeasured in µM

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026