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Study of ALXN2050 in Proliferative Lupus Nephritis (LN) and Immunoglobulin A Nephropathy (IgAN)

Brief Description

The purpose of this clinical trial is to evaluate the safety and efficacy (effectiveness against disease) of the study medication (ALXN2050) in participants with lupus nephritis (LN) or immunoglobulin A nephropathy (IgAN), a rare chronic kidney disease.

Trial Physician / Study Coordinator

Valdivia Guillermo

Email
Site Name

University of New Mexico
1 University of New Mexico, Albuquerque, NM 87131

Sponsor

Alexion Pharmaceuticals, Inc.

Study Drug

ALXN2050

Estimated enrollment

126

Estimated end date

08-24-2026

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.
Find other locations for this trial:
Currently Enrolling
Interventional

RestoreD

Study of ALXN2050 in Proliferative Lupus Nephritis (LN) and Immunoglobulin A Nephropathy (IgAN)

Brief Description

The purpose of this clinical trial is to evaluate the safety and efficacy (effectiveness against disease) of the study medication (ALXN2050) in participants with lupus nephritis (LN) or immunoglobulin A nephropathy (IgAN), a rare chronic kidney disease.

Trial is for people with

Lupus Nephritis (LN) and Immunoglobulin A Nephropathy (IgAN)

Study Goal

This randomized placebo-controlled dose-finding study is to evaluate the safety and efficacy of ALXN2050 in adult participants with Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN).

What is involved for the Patient?

This study will include 126 participants (56 IgAN and 70 LN). The total study duration for each participant will be approximately 3 years. If you qualify and decide to participate in this study, you will be assigned by chance (randomly) to receive ALXN2050 180 mg, or ALXN2050 120 mg, or placebo as oral tablets. The placebo tablet looks like ALXN2050 but does not contain the active ingredient. You will be asked to undergo a number of procedures at your study visits. Before you choose to participate, you should speak with your doctor.

About the drug or intervention

The study drug (ALXN2050) is an oral tablet.

Find other locations for this trial:
Albuquerque, NM
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