Clinical Trial 46191

Tampa, FL 33606


Summary:

You are invited to take part in this research study because you have kidney disease (lupus nephritis) caused by Systemic Lupus Erythematosus (SLE).Systemic Lupus Erythematosus (SLE) is an autoimmune disease,which means your immune system attacks healthy cells in your body by mistake. SLEcan affect many parts of the body, including the skin, joints, and kidneys. The immune system is the body’s way of defending against infections, but in SLE, the immune system does not work normally,and it attacks the body itself.Lupus nephritisis a serious complication of SLE thathappens when the immune system attacks the kidneys and causes damage to them.“Active proliferative lupus nephritis” means that there is inflammation in the kidneys, which can lead to an abnormal amount of protein being spilled into the urine and reductionin the functioning of the kidneys. The normal function of the kidneys is to maintain normal levels of blood mineralsand water and to get rid of waste products. Whether or not someone has active proliferative lupus nephritis or kidney inflammation is determined by looking at a little bit of their kidney tissue under a microscope.Some treatments for SLEsuch as prednisonework by reducing the activity of the immune system. Other treatments for SLE work by targeting just a specific partof the immune system to reduce damage to the body.



1. Is male or female, age ≥ 18 and ≤ 75 years

 

2. Has provided written informed consent prior to participation in the study in accordance with federal, local, and institutional guidelines

 

3. Kidney biopsy within 7 months prior to Screening or during Screening with a histologic diagnosis of LN 

 

4. Has documented elevation of ANAs in the past or currently

 

5. Previously or currently on treatment for Lupus 

 

6. Currently in flare (experiencing symptoms)


Qualified Participants May Receive:

Compensation for time and travel

All study-related assessments, medications and care at no cost


Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.