NCT03526042

Angiotensin-II Receptor Antibodies Blockade With Losartan in Patients With Lupus Nephritis

Angiotensin-II Receptor Antibody Blockade With Losartan in Patients With Lupus Nephritis

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran · Academic / Other
• Sex: All
• Age: 16 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atherosclerosis
• Lupus Nephritis

Interventions

Type	Name	Description
DRUG	Losartan	Competitive blockade of AT1R-antibodies effect by binding to the angiotensin 1 receptor
DRUG	Enalapril	Renin-angiotensin-aldosterone system (RAAS) blockade without any effect on AT1R-antibodies effect or concentration (control group)

Timeline

• Start date: 2017-09-10
• Primary completion: 2019-07-31
• Completion: 2019-10-31
• First posted: 2018-05-16
• Last updated: 2018-05-16

Locations

1 site across 1 country: Mexico