Atherosclerosis Clinical Trial
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | October 31, 2019 |
Est. primary completion date | July 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years to 50 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Mexico | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran | Mexico City |
Lead Sponsor | Collaborator |
---|---|
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran | National Council of Science and Technology, Mexico |
Mexico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 12 months | |
Secondary | Response to treatment | Response to immunosuppressive treatment at 12 months | 12 months | |
Secondary | Arterial pressure | Arterial pressure control recorded by 24-hour ambulatory blood pressure | 12months |
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