Clinical trial NCT03526042: Angiotensin-II Receptor Antibodies Blockade With Losartan in Patients With Lupus Nephritis
Official title: Angiotensin-II Receptor Antibody Blockade With Losartan in Patients With Lupus Nephritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atherosclerosis
Lupus Nephritis
Lead sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Sponsor class: OTHER
Collaborators: name: National Council of Science and Technology, Mexico
First posted: 2018-05-16
Enrollment: 40
Sex: ALL
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open randomized clinical trial with parallel group comparing AT1R-ab blockade with losartan and enalapril as a control group.
Primary purpose: PREVENTION

Brief 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). 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Carotid intima-media thickness change after 12 months of the intervention
timeFrame: 12 months
Secondary outcomes:
measure: Response to treatment
timeFrame: 12 months
measure: Arterial pressure
timeFrame: 12months
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Study officials:
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
name: Luis E Morales-Buenrostro, PhD
role: PRINCIPAL_INVESTIGATOR
References: