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| Name | Class |
|---|---|
| National Council of Science and Technology, Mexico | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Losartan | Experimental | AT1R-ab effect can be blocked with the use of angiotensin-II receptor blockers. The participants will receive 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Losartan | Drug | Competitive blockade of AT1R-antibodies effect by binding to the angiotensin 1 receptor |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Response to treatment | Response to immunosuppressive treatment at 12 months | 12 months |
| Arterial pressure | Arterial pressure control recorded by 24-hour ambulatory blood pressure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luis E Morales-Buenrostro, PhD | Contact | 54870900 | 4142 | luis_buenrostro@yahoo.com.mx |
| Juan M Mejia-Vilet, MD,MSc | Contact | 54870900 | 4142 | jmmejia@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Luis E Morales-Buenrostro, PhD | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran | Recruiting | Mexico City | 14080 | Mexico |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 1, 2016 | Apr 30, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D008181 | Lupus Nephritis |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D019808 | Losartan |
| D057911 | Angiotensin Receptor Antagonists |
| D004656 | Enalapril |
| D000806 | Angiotensin-Converting Enzyme Inhibitors |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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Open randomized clinical trial with parallel group comparing AT1R-ab blockade with losartan and enalapril as a control group.
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| Enalapril | Drug | Renin-angiotensin-aldosterone system (RAAS) blockade without any effect on AT1R-antibodies effect or concentration (control group) |
|
|
| 12months |
| D005921 |
| Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D008180 | Lupus Erythematosus, Systemic |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013777 | Tetrazoles |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D004151 | Dipeptides |
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011480 | Protease Inhibitors |
| D004791 | Enzyme Inhibitors |