AtherosclerosisNCT03526042
Angiotensin-II Receptor Antibodies Blockade With Losartan in Patients With Lupus Nephritis
A study testing Losartan and Enalapril in people with Atherosclerosis and Lupus Nephritis, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
Trial summary
Antibodies directed against angiotensin-II receptor (AT1-Ab) are agonist antibodies previously studied in human diseases such as preeclampsia, transplantation and scleroderma. They act by binding to the AT1 receptor and their effects can be blocked with the use of angiotensin receptor blockers (ARB). Read more about this study
- Who is it for?
- Ages 16 to 50 years
- Conditions the study is for
- Atherosclerosis, Lupus Nephritis
- What is being tested?
- Losartan and Enalapril
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteMexico
- Study dates
- 10 Sep 2017to 31 Oct 2019
- Phase
- Interventional
- 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 16 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Signed consent form for the study
- Biopsy-proven lupus nephritis with proteinuria > 1.5g/g by 24 hour urine protein to creatinine ratio
- Need for immunosuppressive induction to remission therapy according to the treatment physician
- Systemic lupus erythematosus diagnosis based on at least 4 American College of Rheumatology criteria
- Age between 16 and 50 years
Who cannot join
- Patient does not want to participate in the study
- Comorbid disease such as diabetes mellitus with macro/microangiopathy, previous diagnosis of hypertension >5 years, scleroderma
- Comorbid findings in the histopathological analysis of the renal biopsy
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, 14080
Juan M Mejia-Vilet, MD,MSc, 54870900 ext. 4142, jmmejia@hotmail.com
Luis E Morales-Buenrostro, PhD, 54870900 ext. 4142, luis_buenrostro@yahoo.com.mx
About this study
Official title: Angiotensin-II Receptor Antibody Blockade With Losartan in Patients With Lupus Nephritis
Antibodies directed against angiotensin-II receptor (AT1-Ab) are agonist antibodies previously studied in human diseases such as preeclampsia, transplantation and scleroderma. They act by binding to the AT1 receptor and their effects can be blocked with the use of angiotensin receptor blockers (ARB). In this randomized open clinical trial the investigators will study the effect of the blockade of AT1-Ab with losartan in carotid intima-media thickness progression in patients with lupus nephritis compared to patients treated with enalapril.
Read the detailed description
Angiotensin-II type 1 receptor antibodies (AT1R-Ab) are agonist antibodies directed against the second loop of the AT1 receptor. These antibodies have been studied in human diseases such as preeclampsia, transplantation and scleroderma. A previous study from the investigators' group found an elevated prevalence of AT1R-Ab in patients with lupus nephritis. As these antibodies have been linked to atherosclerosis development this open randomized clinical trial was designed to evaluate the effect of AT1R-Ab blockade with losartan compared to the use of enalapril in the progression of carotid intima-media thickness (CIMT) in patients with active lupus nephritis.
Biopsy-proven lupus nephritis patients who tested positive for AT1R-Ab will be performed a CIMT measurement by Doppler ultrasound at the time of the biopsy and then at 12-months follow up.
The primary outcome will be the change in the CIMT in the course of 12 months in both groups.
- Conditions
- Atherosclerosis, Lupus Nephritis
- Being tested
- Losartan, Enalapril
- Medical subject headings
- Atherosclerosis, Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LosartanDrug
Also called Angiotensin receptor blocker
Competitive blockade of AT1R-antibodies effect by binding to the angiotensin 1 receptor
EnalaprilDrug
Also called Angiotensin Converting Enzyme Inhibitor
Renin-angiotensin-aldosterone system (RAAS) blockade without any effect on AT1R-antibodies effect or concentration (control group)
| Study group | Role | What they receive |
|---|---|---|
| Losartan | Experimental | AT1R-ab effect can be blocked with the use of angiotensin-II receptor blockers. The participants will receive losartan. Receives: Drug: Losartan |
| Enalapril | Active comparator | Angiotensin converting enzyme inhibitors are indicated in the management of active lupus nephritis but do not block the effect of AT1R-Ab. Receives: Drug: Enalapril |
What is being measured
The primary outcome is the main question the study is designed to answer.
Carotid intima-media thickness change after 12 months of the intervention
Change in carotid intima-media thickness from baseline thickness at study entry to 12 months of follow up measured by Doppler ultrasound
Measured: 12 months
Secondary outcomes (2)
Response to treatment
Response to immunosuppressive treatment at 12 months
Measured: 12 months
Arterial pressure
Arterial pressure control recorded by 24-hour ambulatory blood pressure
Measured: 12months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2018
- Study start10 Sep 2017
- Primary completion31 Jul 2019 (estimated)
- Study completion31 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open randomized clinical trial with parallel group comparing AT1R-ab blockade with losartan and enalapril as a control group.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Sponsor type
- University, hospital or other
- Collaborators
- National Council of Science and Technology, Mexico
- Responsible party
- Principal investigator, Luis Eduardo Morales Buenrostro, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Investigators
- Luis E Morales-Buenrostro, PhD, Principal investigator, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03526042
- Sponsor's protocol ID
- NMM-1816,16/16-1
- Status last verified
- May 2018
- First submitted
- 16 Apr 2018
- Last updated
- 16 May 2018
- Results posted
- No
- Data monitoring committee
- No
- 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 16 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Angiotensin-II Receptor Antibody Blockade With Losartan in Patients With Lupus Nephritis
- ClinicalTrials.gov ID
- NCT03526042
- Acronym / sponsor ID
- NMM-1816,16/16-1
- Conditions
- Atherosclerosis, Lupus Nephritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranUniversity, hospital or other
- Collaborators
- National Council of Science and Technology, Mexico
- Study start
- 10 Sep 2017 (actual)
- Primary completion
- 31 Jul 2019 (estimated)
- Study completion
- 31 Oct 2019 (estimated)
- First posted
- 16 May 2018 (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.
Antibodies directed against angiotensin-II receptor (AT1-Ab) are agonist antibodies previously studied in human diseases such as preeclampsia, transplantation and scleroderma. They act by binding to the AT1 receptor and their effects can be blocked with the use of angiotensin receptor blockers (ARB). In this randomized open clinical trial the investigators will study the effect of the blockade of AT1-Ab with losartan in carotid intima-media thickness progression in patients with lupus nephritis compared to patients treated with enalapril.
Detailed description
Angiotensin-II type 1 receptor antibodies (AT1R-Ab) are agonist antibodies directed against the second loop of the AT1 receptor. These antibodies have been studied in human diseases such as preeclampsia, transplantation and scleroderma. A previous study from the investigators' group found an elevated prevalence of AT1R-Ab in patients with lupus nephritis. As these antibodies have been linked to atherosclerosis development this open randomized clinical trial was designed to evaluate the effect of AT1R-Ab blockade with losartan compared to the use of enalapril in the progression of carotid intima-media thickness (CIMT) in patients with active lupus nephritis.
Biopsy-proven lupus nephritis patients who tested positive for AT1R-Ab will be performed a CIMT measurement by Doppler ultrasound at the time of the biopsy and then at 12-months follow up.
The primary outcome will be the change in the CIMT in the course of 12 months in both groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open randomized clinical trial with parallel group comparing AT1R-ab blockade with losartan and enalapril as a control group.
| Arm | Type | Receives |
|---|---|---|
| Losartan | Experimental | Drug: LosartanAT1R-ab effect can be blocked with the use of angiotensin-II receptor blockers. The participants will receive losartan. |
| Enalapril | Active comparator | Drug: EnalaprilAngiotensin converting enzyme inhibitors are indicated in the management of active lupus nephritis but do not block the effect of AT1R-Ab. |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Signed consent form for the study
- Biopsy-proven lupus nephritis with proteinuria > 1.5g/g by 24 hour urine protein to creatinine ratio
- Need for immunosuppressive induction to remission therapy according to the treatment physician
- Systemic lupus erythematosus diagnosis based on at least 4 American College of Rheumatology criteria
- Age between 16 and 50 years
Key exclusion criteria (3 listed)
- Patient does not want to participate in the study
- Comorbid disease such as diabetes mellitus with macro/microangiopathy, previous diagnosis of hypertension >5 years, scleroderma
- Comorbid findings in the histopathological analysis of the renal biopsy
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 |
|---|---|---|
| LosartanAlso: Angiotensin receptor blockerCompetitive blockade of AT1R-antibodies effect by binding to the angiotensin 1 receptor | Drug | Losartan |
| EnalaprilAlso: Angiotensin Converting Enzyme InhibitorRenin-angiotensin-aldosterone system (RAAS) blockade without any effect on AT1R-antibodies effect or concentration (control group) | Drug | Enalapril |
Primary outcome
Carotid intima-media thickness change after 12 months of the intervention
Time frame: 12 months
Change in carotid intima-media thickness from baseline thickness at study entry to 12 months of follow up measured by Doppler ultrasound
2 secondary outcomes
Response to treatment
Time frame: 12 months
Arterial pressure
Time frame: 12months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2018.
- Individual participant dataSharing planned: No
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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.
Luis E Morales-Buenrostro, PhD principal investigator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Losartan and Enalapril in people with Atherosclerosis and Lupus Nephritis, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran 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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 16 May 2018. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luis E Morales-Buenrostro, PhD (54870900 ext. 4142, luis_buenrostro@yahoo.com.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Carotid intima-media thickness change after 12 months of the intervention (time frame: 12 months). 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 16 May 2018.