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

NCT05232370 | Completed Phase 2 DMC

• 1 other identifier: UIMER004
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Oxidative Stress

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Superoxide dismutase (SOD) (Antioxidative molecule)

  1 year after renal transplant

• Glutathione peroxidase (GPx) (Antioxidative molecule)

  1 year after renal transplant

• Total Antioxidant Capacity (TAC) (Antioxidative molecule)

  1 year after renal transplant

Study Arms (3)

Control Group

NO INTERVENTION

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)

Enalapril group

EXPERIMENTAL

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

Losartan group

EXPERIMENTAL

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

Interventions

Angiotensin converting enzyme inhibitor DRUG

Angiotensin-converting enzyme inhibitors after Kidney Transplant

Also known as: Enalapril

Enalapril group

Angiotensin Receptor Blockers DRUG

Angiotensin receptor blockers after Kidney Transplant

Also known as: Losartan

Losartan group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Unidad de Investigacion Medica en Enfermedades Renales: lead

Study Sites (1)

Enrique Rojas Campos

Guadalajara, Jalisco, 44320, Mexico

Location

MeSH Terms

Interventions

Angiotensin-Converting Enzyme Inhibitors; Enalapril; Angiotensin Receptor Antagonists; Losartan

Intervention Hierarchy (Ancestors)

Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Dipeptides; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: January 6, 2022
• First Posted: February 9, 2022
• Study Start: January 1, 2022
• Primary Completion: January 6, 2022
• Study Completion: January 6, 2022
• Last Updated: February 9, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)