Oxidative StressPhase 2NCT05232370
The Effect of Enalapril, Losartan or Not Antihypertensive on the Oxidative Status in Renal Transplant Recipients
A Phase 2 study testing Angiotensin converting enzyme inhibitor and Angiotensin Receptor Blockers in people with Oxidative Stress, run by Unidad de Investigacion Medica en Enfermedades Renales at 1 site in Mexico.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Oxidative Stress
- What is being tested?
- Angiotensin converting enzyme inhibitor and Angiotensin Receptor Blockers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteMexico
- Study dates
- 1 Jan 2022to 6 Jan 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 9Show fewer
- Treatment with statins, spironolactone, pentoxifylline, patients
- With neurodegenerative processes
- Those who withdrew the Letter of Consent under Information
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Oxidative Stress
- Being tested
- Angiotensin converting enzyme inhibitor, Angiotensin Receptor Blockers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angiotensin converting enzyme inhibitorDrug
Also called Enalapril
Angiotensin-converting enzyme inhibitors after Kidney Transplant
Angiotensin Receptor BlockersDrug
Also called Losartan
Angiotensin receptor blockers after Kidney Transplant
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Angiotensin Receptor Blockers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Products of lipoperoxidation (LPO) (oxidative stress molecule)
Measured in mM
Measured: 1 year after renal transplant
Nitric Oxide (NO) (oxidative stress molecule)
Measured in µg/mL
Measured: 1 year after renal transplant
Secondary outcomes (3)
Superoxide dismutase (SOD) (Antioxidative molecule)
Measured in U/L
Measured: 1 year after renal transplant
Glutathione peroxidase (GPx) (Antioxidative molecule)
Measured in nmol/min/mL
Measured: 1 year after renal transplant
Total Antioxidant Capacity (TAC) (Antioxidative molecule)
Measured in µM
Measured: 1 year after renal transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2022
- Study start1 Jan 2022
- Primary completion6 Jan 2022
- Study completion6 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxidative StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three groups are made 1. \- Control group: No treatment 2. \- Tratment group: Enalapril 3. \- Treatment group: Losartan
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unidad de Investigacion Medica en Enfermedades Renales
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05232370
- Sponsor's protocol ID
- UIMER004
- Status last verified
- Feb 2022
- First submitted
- 6 Jan 2022
- Last updated
- 9 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Enalapril, Losartan or Not Antihypertensive on the Oxidative Status in Renal Transplant Recipients
- ClinicalTrials.gov ID
- NCT05232370
- Acronym / sponsor ID
- UIMER004
- Conditions
- Oxidative Stress
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Unidad de Investigacion Medica en Enfermedades RenalesUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 6 Jan 2022 (actual)
- Study completion
- 6 Jan 2022 (actual)
- First posted
- 9 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Three groups are made 1. - Control group: No treatment 2. - Tratment group: Enalapril 3. - Treatment group: Losartan
| Arm | Type | Receives |
|---|---|---|
| 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 | Drug: Angiotensin converting enzyme inhibitorRecipients 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 |
| Losartan group | Experimental | Drug: Angiotensin Receptor BlockersRecipients 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Angiotensin converting enzyme inhibitorAlso: EnalaprilAngiotensin-converting enzyme inhibitors after Kidney Transplant | Drug | Enalapril group |
| Angiotensin Receptor BlockersAlso: LosartanAngiotensin receptor blockers after Kidney Transplant | Drug | Losartan group |
Primary outcome
Products of lipoperoxidation (LPO) (oxidative stress molecule)
Time frame: 1 year after renal transplant
Measured in mM
Nitric Oxide (NO) (oxidative stress molecule)
Time frame: 1 year after renal transplant
Measured in µg/mL
3 secondary outcomes
Superoxide dismutase (SOD) (Antioxidative molecule)
Time frame: 1 year after renal transplant
Glutathione peroxidase (GPx) (Antioxidative molecule)
Time frame: 1 year after renal transplant
Total Antioxidant Capacity (TAC) (Antioxidative molecule)
Time frame: 1 year after renal transplant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
- Individual participant dataSharing planned: No
Related trials for Oxidative Stress
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
RecruitingPhase 1
Study of Preoperative Radiation Therapy in Participants With Resectable Recurrent Abdominal Adrenocortical Carcinoma
Adrenocortical Carcinoma (ACC), Recurrent Adrenocortical Carcinoma (ACC)
Recruiting
Acute Effects of Post-Exercise Hyperoxia on Recovery in Cycling
Athletic Performance, Hyperbaric Oxygenation
Recruiting
Dietary Intervention Study on Liver Health in Young Adults
Liver Health
RecruitingObservational study
Oxidative Stress and Inflammatory Biomarkers in Gaucher Disease
Gaucher Disease Type I, Oxidative Stress
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Angiotensin converting enzyme inhibitor and Angiotensin Receptor Blockers in people with Oxidative Stress, run by Unidad de Investigacion Medica en Enfermedades Renales at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Products of lipoperoxidation (LPO) (oxidative stress molecule) (time frame: 1 year after renal transplant). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2022.