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

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.

Study Overview

• Status: Completed
• Conditions: Oxidative Stress
• Intervention / Treatment: Drug: Angiotensin converting enzyme inhibitor; Drug: Angiotensin Receptor Blockers

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.

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Phase 2

Contacts and Locations

Study Locations

• Mexico
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44320
      • Enrique Rojas Campos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; 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 control group (Without losartan or enalapril)
Experimental: Enalapril group; 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	Drug: Angiotensin converting enzyme inhibitor; Angiotensin-converting enzyme inhibitors after Kidney Transplant; Other Names: Enalapril
Experimental: Losartan group; 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	Drug: Angiotensin Receptor Blockers; Angiotensin receptor blockers after Kidney Transplant; Other Names: Losartan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Products of lipoperoxidation (LPO) (oxidative stress molecule)	Measured in mM	1 year after renal transplant
Nitric Oxide (NO) (oxidative stress molecule)	Measured in µg/mL	1 year after renal transplant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Superoxide dismutase (SOD) (Antioxidative molecule)	Measured in U/L	1 year after renal transplant
Glutathione peroxidase (GPx) (Antioxidative molecule)	Measured in nmol/min/mL	1 year after renal transplant
Total Antioxidant Capacity (TAC) (Antioxidative molecule)	Measured in µM	1 year after renal transplant

Collaborators and Investigators

• Sponsor: Unidad de Investigacion Medica en Enfermedades Renales

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): January 6, 2022
• Study Completion (Actual): January 6, 2022

Study Registration Dates

• First Submitted: January 6, 2022
• First Submitted That Met QC Criteria: February 8, 2022
• First Posted (Actual): February 9, 2022

Study Record Updates

• Last Update Posted (Actual): February 9, 2022
• Last Update Submitted That Met QC Criteria: February 8, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Protease Inhibitors; Angiotensin II Type 1 Receptor Blockers; Enalapril; Losartan; Enzyme Inhibitors; Angiotensin-Converting Enzyme Inhibitors; Angiotensin Receptor Antagonists
• Other Study ID Numbers: UIMER004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No