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Currently Enrolling
Interventional

SANCTUARY

Phase 2 ALXN1210-NEPH-202 Study

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.

Email Phone 855-752-2356
Site Name

Houston, TX
77030

Find other locations for this trial:
Currently Enrolling
Interventional

SANCTUARY

Phase 2 ALXN1210-NEPH-202 Study

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.

Eligibility Criteria
Patient Population

IgA Nephropathy or Lupus Nephritis

Age

18 — 26+

History of transplant allowed?

No

History of dialysis allowed?

No

eGFR

30 — > 60

UPCR

1.0 or Less — 3.0 or Above

Permitted medication history

Ace Inhibitors/ARB, Prednisone (Steroids), Cellcept (AKA Mycophenolate), Cytoxan (Cyclophosphamide), Prograf (AKA Tacrolimus), Abatacept, Acthar, Rituximab (AKA Rituxan), Other, None

Patient should be

Neither of These

About the Drug
What is involved for the patient

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.

Sponsor

Alexion, Astra Zeneca Rare Disease

Estimated End Date

September 2024

About the Trial
Study Drug

ALXN1210 also known as ravulizumab or ULTOMIRIS

Study Goal

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).

About the drug or intervention

The study medication is administered intravenously every 8 weeks.

Find other locations for this trial:
Houston, TX (Houston Methodist Research Institute)
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