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Currently Enrolling
Interventional

SANCTUARY

Phase 2 ALXN1210-NEPH-202 Study

Breve descripción

The purpose of this clinical trial is to evaluate the safety and efficacy (effectiveness against disease) of the study medication (ALXN1210 also known as ravulizumab or ULTOMIRIS ®) in participants with lupus nephritis (LN) or immunoglobulin A nephropathy (IgAN), a rare chronic kidney disease.

Correo electrónico Teléfono
Nombre del sitio

Lexington, KY
40506

Patrocinador

Alexion, Astra Zeneca Rare Disease

Fármaco del estudio

ALXN1210 also known as ravulizumab or ULTOMIRIS

Matrícula estimada

120

Fecha de finalización estimada

September 2024

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.
Actualmente inscribiéndose
intervencionista

SANCTUARY

Phase 2 ALXN1210-NEPH-202 Study

Breve descripción

The purpose of this clinical trial is to evaluate the safety and efficacy (effectiveness against disease) of the study medication (ALXN1210 also known as ravulizumab or ULTOMIRIS ®) in participants with lupus nephritis (LN) or immunoglobulin A nephropathy (IgAN), a rare chronic kidney disease.

La prueba es para personas con

IgA Nephropathy or Lupus Nephritis

Objetivo del estudio

This randomized placebo-controlled dose-finding study is to evaluate the safety of ALXN1210 in adult participants with Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN).

¿Qué implica para el paciente?

This study will include 120 participants, 60 with LN and 60 with IgAN. The total study duration for each participant will be approximately 2 years. This clinical trial is a phase 2 randomized placebo controlled clinical trial that is randomized 2:1 treatment to placebo such that if you are enrolled you are twice as likely to receive the study treatment than the placebo. Before you choose to participate, you should speak with your doctor.

Sobre el medicamento o la intervención

The study medication is administered intravenously every 8 weeks.

Lexington, KY (University of Kentucky)
Preguntas frecuentes

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.

 

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