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SLE - AWARE: SLE - A Window into APOL1 Regulation and Expression

IRB Number: 2022-0639

Institutional Review Board, Hospital for Special Surgery

December 07, 2023

The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.

Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.

For further information, see Understanding Clinical Trials.

Principal Investigator

Ashira D. Blazer, MD, MSCI

Co-Investigators

Timothy B. Niewold, MD, FACR
Christele Felix
Andrra Nimoni

Summary

Ancestrally African (AA) lupus patients suffer disproportionately from both lupus kidney disease, known as lupus nephritis (LN), and cardiovascular complications of SLE compared to Europeans. About 13% of AA people have two mutations in a gene called Apolipoprotein L1 (APOL1). These mutations provide protection against a parasitic infection that causes African sleeping sickness, but may also damage the kidneys and blood vessels. The APOL1 gene produces its end protein more when the immune system is activated. Since the immune systems of SLE patients are over-active, APOL1 protein may also be over-produced. In patients who carry the mutations, this may also heighten kidney and blood vessel damage. The goal of this study is to understand how the SLE immune system interacts with the APOL1 gene.
A total number of 120 participants will be enrolled during their usual clinical appointments. We will collect 6 (10ml) tubes of blood one time for most participants. In a smaller group of 30 participants with active SLE, we will ask for a second blood collection 6 months after the first collection.

Inclusion/Exclusion Criteria

Inclusion:

  • Male and female patients age 18 years or older
  • African ancestry by self-report
  • Diagnosis of SLE (fulfill 4 or more ACR/SLICC criteria for the diagnosis of SLE).
  • All individuals must be willing and able to sign a written consent.

Exclusion:

  • Pulse dose corticosteroids within the past 30 days