- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Luis E Morales-Buenrostro, PhD
- Phone Number: 4142 54870900
- Email: luis_buenrostro@yahoo.com.mx
Study Contact Backup
- Name: Juan M Mejia-Vilet, MD,MSc
- Phone Number: 4142 54870900
- Email: jmmejia@hotmail.com
Study Locations
-
-
-
Mexico City, Mexico, 14080
- Recruiting
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
-
Contact:
- Luis E Morales-Buenrostro, PhD
- Phone Number: 4142 54870900
- Email: luis_buenrostro@yahoo.com.mx
-
Contact:
- Juan M Mejia-Vilet, MD,MSc
- Phone Number: 4142 54870900
- Email: jmmejia@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Losartan
AT1R-ab effect can be blocked with the use of angiotensin-II receptor blockers.
The participants will receive losartan.
|
Competitive blockade of AT1R-antibodies effect by binding to the angiotensin 1 receptor
Other Names:
|
Active Comparator: Enalapril
Angiotensin converting enzyme inhibitors are indicated in the management of active lupus nephritis but do not block the effect of AT1R-Ab.
|
Renin-angiotensin-aldosterone system (RAAS) blockade without any effect on AT1R-antibodies effect or concentration (control group)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Carotid intima-media thickness change after 12 months of the intervention
Time Frame: 12 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response to treatment
Time Frame: 12 months
|
Response to immunosuppressive treatment at 12 months
|
12 months
|
Arterial pressure
Time Frame: 12months
|
Arterial pressure control recorded by 24-hour ambulatory blood pressure
|
12months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Luis E Morales-Buenrostro, PhD, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Autoimmune Diseases
- Kidney Diseases
- Urologic Diseases
- Connective Tissue Diseases
- Glomerulonephritis
- Lupus Erythematosus, Systemic
- Atherosclerosis
- Nephritis
- Lupus Nephritis
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Protease Inhibitors
- Angiotensin II Type 1 Receptor Blockers
- Enalapril
- Losartan
- Enzyme Inhibitors
- Angiotensin-Converting Enzyme Inhibitors
- Angiotensin Receptor Antagonists
Other Study ID Numbers
- NMM-1816,16/16-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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