The Effect of Enalapril, Losartan or Not Antihypertensive on the Oxidative Status in Renal Transplant Recipients
- Conditions
- Oxidative Stress
- Interventions
- Registration Number
- NCT05232370
- Lead Sponsor
- Unidad de Investigacion Medica en Enfermedades Renales
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 39
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Enalapril group Angiotensin converting enzyme inhibitor 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 Losartan group Angiotensin Receptor Blockers 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
- Primary Outcome Measures
Name Time Method Products of lipoperoxidation (LPO) (oxidative stress molecule) 1 year after renal transplant Measured in mM
Nitric Oxide (NO) (oxidative stress molecule) 1 year after renal transplant Measured in µg/mL
- Secondary Outcome Measures
Name Time Method Glutathione peroxidase (GPx) (Antioxidative molecule) 1 year after renal transplant Measured in nmol/min/mL
Total Antioxidant Capacity (TAC) (Antioxidative molecule) 1 year after renal transplant Measured in µM
Superoxide dismutase (SOD) (Antioxidative molecule) 1 year after renal transplant Measured in U/L
Trial Locations
- Locations (1)
Enrique Rojas Campos
🇲🇽Guadalajara, Jalisco, Mexico