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

Oxidative Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05232370
• Other study ID #: UIMER004
• Status: Completed
• Phase: Phase 2
• Start date: January 1, 2022
• Est. completion date: January 6, 2022

Study information

• Verified date: February 2022
• Source: Unidad de Investigacion Medica en Enfermedades Renales
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: January 6, 2022
• Est. primary completion date: January 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Oxidative Stress

Intervention

Drug:
• Angiotensin converting enzyme inhibitor
Angiotensin-converting enzyme inhibitors after Kidney Transplant
• Angiotensin Receptor Blockers
Angiotensin receptor blockers after Kidney Transplant

Locations

Country	Name	City	State
Mexico	Enrique Rojas Campos	Guadalajara	Jalisco

Sponsors (1)

Lead Sponsor	Collaborator
Unidad de Investigacion Medica en Enfermedades Renales

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Products of lipoperoxidation (LPO) (oxidative stress molecule)	Measured in mM	1 year after renal transplant
Primary	Nitric Oxide (NO) (oxidative stress molecule)	Measured in µg/mL	1 year after renal transplant
Secondary	Superoxide dismutase (SOD) (Antioxidative molecule)	Measured in U/L	1 year after renal transplant
Secondary	Glutathione peroxidase (GPx) (Antioxidative molecule)	Measured in nmol/min/mL	1 year after renal transplant
Secondary	Total Antioxidant Capacity (TAC) (Antioxidative molecule)	Measured in µM	1 year after renal transplant