Enrique Rojas Campos
Guadalajara, Jalisco, 44320, Mexico
NCT Number: NCT05232370
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.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 2
Guadalajara, Jalisco, 44320, Mexico
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Angiotensin-converting enzyme inhibitors after Kidney Transplant
Other names: Enalapril
Angiotensin receptor blockers after Kidney Transplant
Other names: Losartan
Time frame: 1 year after renal transplant
Measured in mM
Time frame: 1 year after renal transplant
Measured in µg/mL
Time frame: 1 year after renal transplant
Measured in U/L
Time frame: 1 year after renal transplant
Measured in nmol/min/mL
Time frame: 1 year after renal transplant
Measured in µM
Unidad de Investigacion Medica en Enfermedades Renales
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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