Angiotensin-II Receptor Antibodies Blockade With Losartan in Patients With Lupus Nephritis
NCT ID: NCT03526042
Last Updated: 2018-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2017-09-10
2019-10-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Losartan
AT1R-ab effect can be blocked with the use of angiotensin-II receptor blockers. The participants will receive losartan.
Losartan
Competitive blockade of AT1R-antibodies effect by binding to the angiotensin 1 receptor
Enalapril
Angiotensin converting enzyme inhibitors are indicated in the management of active lupus nephritis but do not block the effect of AT1R-Ab.
Enalapril
Renin-angiotensin-aldosterone system (RAAS) blockade without any effect on AT1R-antibodies effect or concentration (control group)
Interventions
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Losartan
Competitive blockade of AT1R-antibodies effect by binding to the angiotensin 1 receptor
Enalapril
Renin-angiotensin-aldosterone system (RAAS) blockade without any effect on AT1R-antibodies effect or concentration (control group)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
16 Years
50 Years
ALL
No
Sponsors
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National Council of Science and Technology, Mexico
OTHER
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
OTHER
Responsible Party
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Luis Eduardo Morales Buenrostro
Clinical Professor of Nephrology
Principal Investigators
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Luis E Morales-Buenrostro, PhD
Role: PRINCIPAL_INVESTIGATOR
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Locations
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Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, , Mexico
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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NMM-1816,16/16-1
Identifier Type: -
Identifier Source: org_study_id
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