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OpenTrials
Completed

NCT Number: NCT05232370

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Enrique Rojas Campos

Guadalajara, Jalisco, 44320, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Angiotensin Converting Enzyme Inhibitor

Drug

Angiotensin-converting enzyme inhibitors after Kidney Transplant

Other names: Enalapril

Angiotensin Receptor Blockers

Drug

Angiotensin receptor blockers after Kidney Transplant

Other names: Losartan

Primary outcomes

  1. Products of lipoperoxidation (LPO) (oxidative stress molecule)

    Time frame: 1 year after renal transplant

    Measured in mM

  2. Nitric Oxide (NO) (oxidative stress molecule)

    Time frame: 1 year after renal transplant

    Measured in µg/mL

Secondary outcomes

  1. Superoxide dismutase (SOD) (Antioxidative molecule)

    Time frame: 1 year after renal transplant

    Measured in U/L

  2. Glutathione peroxidase (GPx) (Antioxidative molecule)

    Time frame: 1 year after renal transplant

    Measured in nmol/min/mL

  3. Total Antioxidant Capacity (TAC) (Antioxidative molecule)

    Time frame: 1 year after renal transplant

    Measured in µM

Sponsors and collaborators

Lead sponsor

Unidad de Investigacion Medica en Enfermedades Renales

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 9, 2022
Registry last updated
Feb 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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