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

May 14, 2018 updated by: Luis Eduardo Morales Buenrostro, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

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.

Study Overview

Status

Unknown

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

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Mexico
      • Mexico City, Mexico, 14080
        • Recruiting
        • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Drug: Losartan
Competitive blockade of AT1R-antibodies effect by binding to the angiotensin 1 receptor
Other Names:
  • Angiotensin receptor blocker
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.
Drug: Enalapril
Renin-angiotensin-aldosterone system (RAAS) blockade without any effect on AT1R-antibodies effect or concentration (control group)
Other Names:
  • Angiotensin Converting Enzyme Inhibitor

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

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Collaborators

National Council of Science and Technology, Mexico

Investigators

  • Principal Investigator: Luis E Morales-Buenrostro, PhD, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 10, 2017

Primary Completion (Anticipated)

July 31, 2019

Study Completion (Anticipated)

October 31, 2019

Study Registration Dates

First Submitted

April 16, 2018

First Submitted That Met QC Criteria

May 14, 2018

First Posted (Actual)

May 16, 2018

Study Record Updates

Last Update Posted (Actual)

May 16, 2018

Last Update Submitted That Met QC Criteria

May 14, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMM-1816,16/16-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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