Currently Enrolling
Interventional

Felzartamab

A Phase IIa, Open-Label, 2-Arm Multicenter Clinical Trial to Evaluate the Efficacy, Safety and PK/PD of the Human Anti-CD38 Antibody MOR202 in Anti-PLA2R Antibody Positive Membranous Nephropathy (NewPLACE)

Brief Description

Open-label, 2-arm, multicenter clinical trial to assess safety, efficacy and PK/PD of MOR202 in anti-PLA2R antibody positive membranous nephropathy (aMN)

Trial Physician / Study Coordinator

Ping-Chin Lai

Email
Site Name

China Medical University Hospital
Department of Internal Medicine / Division of Nephrology, 2 Yude Road, 40447, Taichung City, Taiwan

Estimated enrollment

22

Estimated end date

Last patient last value September 2023

If there is not a site for a clinical trial nearby, you can ask the study team about the possibility of travel reimbursements (i.e., paying you back for your travel costs). Alternatively, you can ask about the possibility of participating from home.
Currently Enrolling
Interventional

Felzartamab

A Phase IIa, Open-Label, 2-Arm Multicenter Clinical Trial to Evaluate the Efficacy, Safety and PK/PD of the Human Anti-CD38 Antibody MOR202 in Anti-PLA2R Antibody Positive Membranous Nephropathy (NewPLACE)

Brief Description

Open-label, 2-arm, multicenter clinical trial to assess safety, efficacy and PK/PD of MOR202 in anti-PLA2R antibody positive membranous nephropathy (aMN)

Trial is for people with

anti-PLA2R antibody positive membranous Nephropathy

Study Goal

NewPLACE seeks to investigate an innovative treatment option for anti-PLA2R positive membranous nephropathy

What is involved for the Patient?

If you agree to join this study, your study participation will last for up to 26 months. Twenty visits comprise the screening phase, treatment phase, and follow-up phase in which you will allow the sponsor to access your medical history and biosamples such as blood and urine and perhaps biopsy tissue will be collected. You will receive 2 or 5 intravenous infusions of MOR202. A repeat treatment will be applied depending on the response to treatment in the first three months.

About the drug or intervention

MOR202 is a recombinant purified human immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that binds to human CD38. It is in clinical development for multiple myeloma (MM) and is now being further developed for anti-PLA2R antibody positive membranous nephropathy (aMN) as well as other autoimmune diseases.

Taichung City, Taiwan
Frequently Asked Questions

Nephrotic Syndrome is not a disease itself, but rather a group of signs and symptoms that result from damage in the part of the kidney that filters blood (glomeruli).

Common symptoms include:

  • Foamy urine (called proteinuria) caused by protein “spilling” into the urine
  • Severe swelling in parts of the body, most noticeably around the eyes, hands, feet, and abdomen (called edema)
  • Weight gain due to a buildup of extra fluid
  • Fatigue
  • Loss of appetite
  • Low levels of protein in the blood (hypoalbuminemia)
  • Higher than normal fat and cholesterol levels in the blood (hyperlipidemia)

Nephrotic Syndrome can typically be diagnosed with a urine test.

Nephrotic Syndrome can be “primary” or “secondary” in nature.

Diseases that affect only the kidneys are called primary causes of Nephrotic Syndrome. Doctors often call these diseases “idiopathic,” which means that they arise from an unknown cause. Some of these diseases include:

  • Minimal Change Disease (MCD) – most common in children
  • Focal Segmental Glomerulosclerosis (FSGS)
  • Membranous Nephropathy (MN) – most common in adults
  • IgA Nephropathy (IgAN)

Secondary Nephrotic Syndrome is caused by an underlying, systemic condition like diabetes, lupus, HIV, and others.

The Kidney Health Gateway is a website owned and operated by NephCure Kidney International. The purpose of this website is to help patients with rare forms of primary Nephrotic Syndrome get connected to expert care and cutting-edge treatment options. By answering a few questions about you or your loved one’s condition, we can provide you with a list of clinical trials and/or expert doctors in your area.

If you have additional questions, please visit NephCure.org or email Info@NephCure.org.

 

See other frequently asked questions
Did you know that some forms of kidney disease can be genetic?Researchers are continually discovering genetic causes of Nephrotic Syndrome.

Learn more about genetic causes of kidney disease and find out if you may be affected.